Bio-Medicus™
Cannula CB98805-103 BIO-MED 12ART 0 Hole
3manufacturers in China registered for this device type
223catalogue numbers in this listing
31510(k) clearances naming this product code
15recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | DWF |
| Device type | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4210 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K143083 |
| Record published | 2016-04-23 |
| Record revised | 2025-02-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature up to 40 °C |
| Packaging | Pack of 5 |
| Sizes | Length 10 to 180 cm; catheter gauge 8 to 29 Fr; outer diameter 0.635 to 0.97 mm; needle gauge 18 G; guidewire length 60 to 180 cm; guidewire diameter 0.635 to 0.965 mm |
| Distribution end date | 2026-01-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 96820-108 | Catheter Gauge 8.0 Fr | In distribution | |
| CB96570-021 | Catheter Gauge 21.0 Fr | In distribution | |
| 96370-025 | Catheter Gauge 25.0 Fr | In distribution | |
| CB96570-019 | Catheter Gauge 19.0 Fr | In distribution | |
| CB98805-104 | Guidewire.97MM x100 CM | In distribution | |
| 96670-117 | Length 64.8 cm | In distribution | |
| 96600-115 | Length 180.0 cm | In distribution | |
| 96600-125 | Length 180.0 cm | In distribution | |
| 96670-121 | Length 69.9 cm | In distribution | |
| 96530-123 | Catheter Gauge 23.0 Fr | In distribution | |
| 96600-119 | Catheter Gauge 19.0 Fr | In distribution | |
| 96600-119 | Catheter Gauge 19.0 Fr | In distribution | |
| CB96345-027 | Length 50.0 cm | In distribution | |
| CB96670-017 | Catheter Gauge 17.0 Fr | In distribution | |
| CB96670-019 | Catheter Gauge 19.0 Fr | In distribution | |
| 96530-119 | Length 31.8 cm | In distribution | |
| 96552 | 1 x 8 Fr/10 Fr, 1 x 12 Fr/14 Fr, 1 x 16 Fr/18 Fr | 5 | In distribution |
| CB96570-017 | Length 18.0 cm | In distribution | |
| 96830-110 | Length 22.9 cm | In distribution | |
| 96670-129 | Catheter Gauge 29.0 Fr | In distribution | |
| 96570-121 | Length 31.8 cm | In distribution | |
| 96820-010 | Catheter Gauge 10.0 Fr | In distribution | |
| CB96825-014 | Catheter Gauge 14.0 Fr | In distribution | |
| 96553 | 1 X 8 Fr/10 Fr, 1 x 12 Fr/14 Fr | 5 | In distribution |
| 96530-115 | Catheter Gauge 15.0 Fr | In distribution | |
| 96880-019 | Length 60.0 cm | In distribution | |
| 96570-019 | Length 18.0 cm | In distribution | |
| 96830-112 | Length 22.9 cm | In distribution | |
| 96570-019 | Catheter Gauge 19.0 Fr | In distribution | |
| CB96835-012 | Catheter Gauge 12.0 Fr | In distribution | |
| CB96825-010 | Catheter Gauge 10.0 Fr | In distribution | |
| 96830-114 | Length 22.9 cm | In distribution | |
| 96530-125 | Length 31.8 cm | In distribution | |
| CB96835-012 | Length 10.0 cm | In distribution | |
| 96830-110 | Catheter Gauge 10.0 Fr | In distribution | |
| 96570-115 | Catheter Gauge 15.0 Fr | In distribution | |
| 96530-117 | Length 31.8 cm | In distribution | |
| 96820-008 | Catheter Gauge 8.0 Fr | In distribution | |
| 96530-117 | Catheter Gauge 17.0 Fr | In distribution | |
| 96600-123 | Catheter Gauge 23.0 Fr | In distribution | |
| 96530-125 | Length 31.8 cm | In distribution | |
| 96670-115 | Catheter Gauge 15.0 Fr | In distribution | |
| 96551 | Needle Gauge 18.0 G | 5 | In distribution |
| 96530-121 | Length 31.8 cm | In distribution | |
| 96570-021 | Length 18.0 cm | In distribution | |
| 96600-129 | Catheter Gauge 29.0 Fr | In distribution | |
| 96600-129 | Catheter Gauge 29.0 Fr | In distribution | |
| 96570-017 | Length 18.0 cm | In distribution | |
| 96570-017 | Catheter Gauge 17.0 Fr | In distribution | |
| 96670-123 | Length 76.2 cm | In distribution | |
| 96570-117 | Catheter Gauge 17.0 Fr | In distribution | |
| 96600-123 | Length 76.2 cm | In distribution | |
| 96820-112 | Catheter Gauge 12.0 Fr | In distribution | |
| 96600-117 | Catheter Gauge 17.0 Fr | In distribution | |
| 96830-014 | Length 10.0 cm | In distribution | |
| 96570-125 | Length 31.8 cm | In distribution | |
| CB96825-010 | Catheter Gauge 10.0 Fr | In distribution | |
| CB96570-015 | Length 18.0 cm | In distribution | |
| 96570-021 | Length 18.0 cm | In distribution | |
| 96830-108 | Catheter Gauge 8.0 Fr | In distribution | |
| 96670-021 | Length 50.0 cm | In distribution | |
| 96553 | Length 60.0 cm | In distribution | |
| 96570-123 | Length 31.8 cm | In distribution | |
| 96530-121 | Length 31.8 cm | In distribution | |
| 96530-125 | Length 31.8 cm | In distribution | |
| 96552 | Length 100.0 cm | 5 | In distribution |
| CB96825-008 | Catheter Gauge 8.0 Fr | In distribution | |
| 96551 | Outer Diameter 0.965 mm | 5 | In distribution |
| 96530-121 | Catheter Gauge 21.0 Fr | In distribution | |
| 96670-017 | Catheter Gauge 17.0 Fr | In distribution | |
| CB98805-105 | Catheter Gauge 12.0 Fr | In distribution | |
| CB96670-015 | Length 50.0 cm | In distribution | |
| CB96345-023 | Catheter Gauge 23.0 Fr | In distribution | |
| CB98805-103 | Length 10.0 cm | In distribution | |
| CB96670-015 | Catheter Gauge 15.0 Fr | In distribution | |
| 96600-115 | Length 64.8 cm | In distribution | |
| CB98805-102 | Guidewire.97MM x100 CM | In distribution | |
| CB96835-010 | Length 10.0 cm | In distribution | |
| 96880-021 | Length 60.0 cm | In distribution | |
| 96600-121 | Catheter Gauge 21.0 Fr | In distribution | |
| CB96345-023 | Catheter Gauge 23.0 Fr | In distribution | |
| 96600-115 | Length 64.8 cm | In distribution | |
| CB96670-017 | Catheter Gauge 17.0 Fr | In distribution | |
| CB96570-017 | Length 18.0 cm | In distribution | |
| 96530-115 | Catheter Gauge 15.0 Fr | In distribution | |
| 96530-119 | Catheter Gauge 19.0 Fr | In distribution | |
| 96570-119 | Length 31.8 cm | In distribution | |
| 96830-108 | Length 22.9 cm | In distribution | |
| 96570-117 | Length 31.8 cm | In distribution | |
| 96670-123 | Length 76.2 cm | In distribution | |
| CB96835-008 | Length 10.0 cm | In distribution | |
| 96600-121 | Length 180.0 cm | In distribution | |
| 96600-127 | Catheter Gauge 27.0 Fr | In distribution | |
| 96880-025 | Catheter Gauge 25.0 Fr | In distribution | |
| CB96825-012 | Length 10.0 cm | In distribution | |
| CB96825-008 | Length 10.0 cm | In distribution | |
| CB96345-029 | Catheter Gauge 29.0 Fr | In distribution | |
| 96820-014 | Catheter Gauge 14.0 Fr | In distribution | |
| 96570-115 | Catheter Gauge 15.0 Fr | In distribution | |
| 96670-119 | Catheter Gauge 19.0 Fr | In distribution | |
| 96600-125 | Catheter Gauge 25.0 Fr | In distribution | |
| CB96570-015 | Catheter Gauge 15.0 Fr | In distribution | |
| CB96835-008 | Length 10.0 cm | In distribution | |
| 96670-019 | Catheter Gauge 19.0 Fr | In distribution | |
| 96600-117 | Catheter Gauge 17.0 Fr | In distribution | |
| CB96670-021 | Length 50.0 cm | In distribution | |
| CB96825-012 | Length 10.0 cm | In distribution | |
| 96820-012 | Length 10.0 cm | In distribution | |
| CB96835-008 | Catheter Gauge 8.0 Fr | In distribution | |
| CB96345-027 | Length 50.0 cm | In distribution | |
| CB96670-021 | Catheter Gauge 21.0 Fr | In distribution | |
| 96830-112 | Catheter Gauge 12.0 Fr | In distribution | |
| CB96825-008 | Catheter Gauge 8.0 Fr | In distribution | |
| CB96835-014 | Length 10.0 cm | In distribution | |
| 96820-112 | Length 22.9 cm | In distribution | |
| 96820-114 | Length 22.9 cm | In distribution | |
| 96880-025 | Length 60.0 cm | In distribution | |
| 96570-119 | Catheter Gauge 19.0 Fr | In distribution | |
| 96600-119 | Length 69.9 cm | In distribution | |
| CB96570-021 | Catheter Gauge 21.0 Fr | In distribution | |
| 96600-123 | Outer Diameter 0.97 mm | In distribution | |
| 96820-108 | Length 22.9 cm | In distribution | |
| 96670-015 | Length 50.0 cm | In distribution | |
| 96670-125 | Length 76.2 cm | In distribution | |
| 96370-029 | Catheter Gauge 29.0 Fr | In distribution | |
| 96530-123 | Catheter Gauge 23.0 Fr | In distribution | |
| 96530-117 | Catheter Gauge 17.0 Fr | In distribution | |
| CB96345-029 | Length 50.0 cm | In distribution | |
| 96820-110 | Length 22.9 cm | In distribution | |
| CB96835-014 | Length 10.0 cm | In distribution | |
| CB96345-025 | Catheter Gauge 25.0 Fr | In distribution | |
| 96570-121 | Length 31.8 cm | In distribution | |
| 96570-115 | Catheter Gauge 15.0 Fr | In distribution | |
| 96880-019 | Length 60.0 cm | In distribution | |
| 96370-027 | Catheter Gauge 27.0 Fr | In distribution | |
| 96570-123 | Length 31.8 cm | In distribution | |
| 96530-115 | Catheter Gauge 15.0 Fr | In distribution | |
| 96670-127 | Length 76.2 cm | In distribution | |
| CB96825-014 | Length 10.0 cm | In distribution | |
| 96820-114 | Length 22.9 cm | In distribution | |
| CB96670-019 | Length 50.0 cm | In distribution | |
| 96830-008 | Length 10.0 cm | In distribution | |
| CB96345-025 | Length 50.0 cm | In distribution | |
| 96880-021 | Length 60.0 cm | In distribution | |
| 96600-121 | Catheter Gauge 21.0 Fr | In distribution | |
| 96600-117 | Length 180.0 cm | In distribution | |
| 96530-119 | Length 31.8 cm | In distribution | |
| 96570-015 | Length 18.0 cm | In distribution | |
| CB96570-019 | Length 18.0 cm | In distribution | |
| 96830-114 | Length 22.9 cm | In distribution | |
| 96530-123 | Length 31.8 cm | In distribution | |
| 96370-023 | Catheter Gauge 23.0 Fr | In distribution | |
| 96570-015 | Catheter Gauge 15.0 Fr | In distribution | |
| 96570-125 | Length 31.8 cm | In distribution | |
| CB96835-010 | Length 10.0 cm | In distribution | |
| 96820-110 | Catheter Gauge 10.0 Fr | In distribution | |
| 96830-010 | Length 10.0 cm | In distribution | |
| 96600-125 | Length 76.2 cm | In distribution | |
| CB96570-017 | Catheter Gauge 17.0 Fr | Withdrawn | |
| CB98805-103 | Length 10.0 cm | Withdrawn | |
| 98800-126 | Length 10.0 cm | Withdrawn | |
| CB98005-140 | Catheter Gauge 17.0 Fr | Withdrawn | |
| CB96345-023 | Length 50.0 cm | Withdrawn | |
| CB96570-021 | Catheter Gauge 21.0 Fr | Withdrawn | |
| CB98805-110 | Catheter Gauge 8.0 Fr | Withdrawn | |
| 98800-110 | Length 11.0 cm | Withdrawn | |
| 98000-155 | Catheter Gauge 23.0 Fr | Withdrawn | |
| CB98805-105 | Length 11.0 cm | Withdrawn | |
| CB96670-021 | Length 50.0 cm | Withdrawn | |
| 98800-128 | Catheter Gauge 12.0 Fr | Withdrawn | |
| CB96345-027 | Length 50.0 cm | Withdrawn | |
| 96830-012 | Catheter Gauge 12.0 Fr | Withdrawn | |
| CB98005-138 | Catheter Gauge 23.0 Fr | Withdrawn | |
| CB96670-017 | Catheter Gauge 17.0 Fr | Withdrawn | |
| 98000-105 | Catheter Gauge 21.0 Fr | Withdrawn | |
| CB98805-106 | Length 10.0 cm | Withdrawn | |
| CB98805-102 | Length 11.0 cm | Withdrawn | |
| CB98805-106 | Length 10.0 cm | Withdrawn | |
| 98000-156 | Length 15.0 cm | Withdrawn | |
| CB96570-021 | Length 18.0 cm | Withdrawn | |
| CB98805-103 | Catheter Gauge 12.0 Fr | Withdrawn | |
| 98000-106 | Length 18.0 cm | Withdrawn | |
| CB96835-014 | Length 19.0 cm | Withdrawn | |
| CB96345-029 | Catheter Gauge 29.0 Fr | Withdrawn | |
| CB96345-025 | Length 50.0 cm | Withdrawn | |
| 96600-127 | Catheter Gauge 27.0 Fr | Withdrawn | |
| 98800-142 | Catheter Gauge 14.0 Fr | Withdrawn | |
| CB96570-017 | Catheter Gauge 17.0 Fr | Withdrawn | |
| CB98805-102 | Catheter Gauge 14.0 Fr | Withdrawn | |
| 98800-131 | Catheter Gauge 10.0 Fr | Withdrawn | |
| CB96570-015 | Length 18.0 cm | Withdrawn | |
| CB98805-104 | Length 10.0 cm | Withdrawn | |
| CB96570-015 | Catheter Gauge 15.0 Fr | Withdrawn | |
| CB96670-015 | Catheter Gauge 15.0 Fr | Withdrawn | |
| CB98805-106 | Catheter Gauge 14.0 Fr | Withdrawn | |
| 98000-106 | Length 18.0 cm | Withdrawn | |
| CB98005-139 | Length 18.0 cm | Withdrawn | |
| CB98805-105 | Length 10.0 cm | Withdrawn | |
| 96550 | 5 | Withdrawn | |
| 98800-108 | Length 10.0 cm | Withdrawn | |
| CB98805-104 | Length 10.0 cm | Withdrawn | |
| CB98805-103 | Catheter Gauge 12.0 Fr | Withdrawn | |
| CB96835-010 | Catheter Gauge 10.0 Fr | Withdrawn | |
| CB96825-012 | Catheter Gauge 12.0 Fr | Withdrawn | |
| 98000-105 | Length 18.0 cm | Withdrawn | |
| CB96670-019 | Length 50.0 cm | Withdrawn | |
| CB96570-019 | Catheter Gauge 19.0 Fr | Withdrawn | |
| 98800-140 | Catheter Gauge 12.0 Fr | Withdrawn | |
| CB96825-010 | Catheter Gauge 10.0 Fr | Withdrawn | |
| CB96835-012 | Length 19.0 cm | Withdrawn | |
| 98800-130 | Length 10.0 cm | Withdrawn | |
| 98800-109 | Catheter Gauge 10.0 Fr | Withdrawn | |
| CB98805-110 | Withdrawn | ||
| CB98805-104 | Length 10.0 cm | Withdrawn | |
| CB98805-102 | Length 10.0 cm | Withdrawn | |
| CB98805-106 | Catheter Gauge 14.0 Fr | Withdrawn | |
| 98000-158 | Length 15.0 cm | Withdrawn | |
| 98000-157 | Catheter Gauge 17.0 Fr | Withdrawn | |
| 98800-115 | Length 11.0 cm | Withdrawn | |
| CB96570-015 | Length 18.0 cm | Withdrawn | |
| CB96825-014 | Length 19.0 cm | Withdrawn | |
| CB98805-105 | Length 10.0 cm | Withdrawn | |
| CB96570-019 | Length 18.0 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic, Inc. | 5,237 |
| DLP™ | Medtronic, Inc. | 804 |
| Pemco Inc | Pemco, Inc. | 137 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Maquet Cardiopulmonary GmbH | 135 |
| Venous cardiopulmonary bypass cannula | LivaNova USA, Inc. | 97 |
| Eopa™ | Medtronic, Inc. | 87 |
| Surge Cardiovascular | MED Michigan Holdings LLC | 80 |
| Arterial cardiopulmonary bypass cannula | LivaNova USA, Inc. | 79 |
| MC2™ | Medtronic, Inc. | 66 |
| Select Series® | Medtronic, Inc. | 63 |
| Edwards Lifesciences Aortic Perfusion Cannula | Edwards Lifesciences Technology Sarl | 52 |
| PureFlex Arterial Cannulae | Sorin Group Italia SRL | 36 |
Showing 12 of 372. All products under Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260195 | 2026-04-23 |
| K253203 | 2026-02-19 |
| K253998 | 2026-01-20 |
| K251258 | 2025-06-20 |
| K231206 | 2023-12-07 |
| K230960 | 2023-05-04 |
| K201100 | 2021-07-15 |
| K190557 | 2019-04-03 |
| K182586 | 2018-10-19 |
| K180453 | 2018-03-22 |
| K180456 | 2018-03-22 |
| K171979 | 2017-10-27 |
| K171308 | 2017-06-02 |
| K153598 | 2016-01-15 |
| K151523 | 2015-07-16 |
| K150567 | 2015-04-09 |
| K143083 | 2015-03-25 |
| K150422 | 2015-03-20 |
| K143107 | 2015-01-07 |
| K142673 | 2014-11-18 |
| K141951 | 2014-08-15 |
| K140192 | 2014-05-22 |
| K140165 | 2014-05-20 |
| K132995 | 2013-10-31 |
| K131269 | 2013-07-10 |
| K123762 | 2013-03-27 |
| K122913 | 2012-10-19 |
| K120988 | 2012-07-25 |
| K120987 | 2012-06-06 |
| K120612 | 2012-05-25 |
| K100274 | 2010-05-10 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Perfusion Systems | 510(k) number | 2026-05-25 | Class II | Packaging | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. | ||
| Medtronic Perfusion Systems | 510(k) number | 2026-05-25 | Class II | Packaging | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. | ||
| Medtronic Perfusion Systems | 510(k) number | 2021-09-13 | Class II | Under Investigation by firm | There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers. | 168 kits | |
| Medtronic Perfusion Systems | 510(k) number | 2008-05-09 | Not classified | Nonconforming Material/Component | Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic’s heparin supplier recently | 17 US, 29 OUS | 2012-05-08 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-01-30 | Class II | Under Investigation by firm | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. | 19483 total (7669 US, 11814 OUS) | 2014-10-06 |
| 2014-01-30 | Class II | Under Investigation by firm | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. | 19483 total (7669 US, 11814 OUS) | 2014-10-06 |
| 2014-01-30 | Class II | Under Investigation by firm | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. | 19483 total (7669 US, 11814 OUS) | 2014-10-06 |
| 2014-01-30 | Class II | Under Investigation by firm | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. | 19483 total (7669 US, 11814 OUS) | 2014-10-06 |
| 2014-01-30 | Class II | Under Investigation by firm | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. | 19483 total (7669 US, 11814 OUS) | 2014-10-06 |
| 2013-07-17 | Class II | Process control | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic. | 758 | 2014-02-04 |
| 2013-02-19 | Class II | Nonconforming Material/Component | Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula. | 13,691 (6711 USA; 6980 OUS) | 2013-11-21 |
| 2012-11-19 | Class II | Package design/selection | Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility. | 1552 | 2013-04-04 |
| 2011-12-14 | Not classified | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructi | 614,382 | 2014-05-22 |
| 2011-12-14 | Not classified | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructi | 336,171 | 2014-05-22 |
| 2011-12-14 | Not classified | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructi | 14,306 | 2014-05-22 |
| 2011-12-14 | Not classified | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructi | 139,777 | 2014-05-22 |
| 2011-12-14 | Not classified | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructi | 883 | 2014-05-22 |
| 2011-12-14 | Not classified | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructi | 120,438 | 2014-05-22 |
| 2004-09-15 | Not classified | Other | Spiral tip from DLP VAD cannula may be loose and potentially detach during use. | 753 units, 203 distributed in US to 24 customers. | 2005-11-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.