Intersept™
CON CB4621 Intspt Bioact 1/2X1/2 LL 10PK
1manufacturer
103catalogue numbers in this listing
16510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifemotion Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | DTZ |
| Device type | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K171979 |
| Record published | 2020-03-01 |
| Record revised | 2022-12-08 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Handling environment temperature up to 40 °C; Special storage condition: Store the product at room temperature. |
| Packaging | Pack of 10, pack of 5, pack of 2, pack of 4, pack of 6, pack of 20 |
| Sizes | Outer diameter 4.8 to 12.7 mm; length 1.8 m; lumen/inner diameter 6.4 to 12.7 mm |
| Distribution end date | 2026-03-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CB4621 | Outer Diameter 12.7 mm | In distribution |
| CB2995 | 12.7 MM Port Outer Diameter | In distribution |
| CB4625 | 6.4 MM Port Outer Diameter | In distribution |
| CB4628 | Outer Diameter 9.5 mm | In distribution |
| CB2993 | Length 1.8 m | In distribution |
| CB4618 | 9.5 MM Port Outer Diameter | In distribution |
| CB4633 | Outer Diameter 12.7 mm | In distribution |
| CB4619 | 4.8 MM Port Outer Diameter | In distribution |
| CB1351 | In distribution | |
| CB4624 | 9.5 MM Port Outer Diameter | In distribution |
| CB4633 | 9.5 MM Port Outer Diameter | In distribution |
| CB4613 | 12.7 MM Port Outer Diameter | In distribution |
| CB4617 | 4.8 MM Port Outer Diameter | In distribution |
| CB4622 | Outer Diameter 12.7 mm | In distribution |
| CB4632 | Outer Diameter 6.4 mm | In distribution |
| CB6H78R | In distribution | |
| CB4625 | Outer Diameter 6.4 mm | In distribution |
| CB4620 | 6.4 MM Port Outer Diameter | In distribution |
| CB4630 | 6.4 MM Port Outer Diameter | In distribution |
| CB4619 | Outer Diameter 4.8 mm | In distribution |
| CB4634 | 12.7 MM Port Outer Diameter | In distribution |
| CB6H77R | In distribution | |
| CB4629 | Outer Diameter 6.4 mm | In distribution |
| CB4613 | Outer Diameter 12.7 mm | In distribution |
| CB3B38R2 | In distribution | |
| CB2995 | 2.4 mm Wall Thickness | In distribution |
| CB4616 | 12.7 MM Port Outer Diameter | In distribution |
| CB6H76R | In distribution | |
| CB4617 | Outer Diameter 4.8 mm | In distribution |
| CB4616 | Outer Diameter 12.7 mm | In distribution |
| CB4626 | 6.4 MM Port Outer Diameter | In distribution |
| CB4629 | 6.4 MM Port Outer Diameter | In distribution |
| CB4632 | 6.4 MM Port Outer Diameter | In distribution |
| CB4621 | 12.7 MM Port Outer Diameter | In distribution |
| CB4630 | Outer Diameter 6.4 mm | In distribution |
| CB4614 | Outer Diameter 6.4 mm | In distribution |
| CB4622 | 12.7 MM Port Outer Diameter | In distribution |
| CB4615 | Outer Diameter 4.8 mm | In distribution |
| CB4623 | 9.5 MM Port Outer Diameter | In distribution |
| CB4626 | Outer Diameter 6.4 mm | In distribution |
| CB4631 | 4.8 MM Port Outer Diameter | In distribution |
| CB4615 | 4.8 MM Port Outer Diameter | In distribution |
| CB4614 | 6.4 MM Port Outer Diameter | In distribution |
| CB4624 | In distribution | |
| CB4620 | Outer Diameter 6.4 mm | In distribution |
| CB4624 | Outer Diameter 9.5 mm | In distribution |
| CB4618 | Outer Diameter 9.5 mm | In distribution |
| CB4631 | Outer Diameter 4.8 mm | In distribution |
| CB4628 | 9.5 MM Port Outer Diameter | In distribution |
| CB2960-1 | Withdrawn | |
| CB5U82R | Withdrawn | |
| CB5U83R | Withdrawn | |
| CB4634 | Withdrawn | |
| CB4625 | Withdrawn | |
| CB1M45R | Withdrawn | |
| CB5U81R | Withdrawn | |
| CB4629 | Withdrawn | |
| CB3M74R1 | Withdrawn | |
| CB4626 | Withdrawn | |
| CB2F42R | Withdrawn | |
| CB4628 | Withdrawn | |
| CB4618 | Withdrawn | |
| CB4619 | Withdrawn | |
| CB4617 | Withdrawn | |
| CB5R47R | Withdrawn | |
| 6151 | 6.4 MM Port Outer Diameter | Withdrawn |
| CB5032 | Withdrawn | |
| CB2994 | 2.4 mm Wall Thickness | Withdrawn |
| CB4631 | Withdrawn | |
| CB4J09R | Withdrawn | |
| CB4616 | Withdrawn | |
| CB1Z14R1 | Withdrawn | |
| CB4G21R19 | Withdrawn | |
| CB4620 | Withdrawn | |
| CB2993 | Length 1.8 m | Withdrawn |
| CB4632 | Withdrawn | |
| CB5U88R | Withdrawn | |
| CB4614 | Withdrawn | |
| CB0Y36R | Withdrawn | |
| CB4615 | Withdrawn | |
| CB1351 | Withdrawn | |
| CB3G21R1 | Withdrawn | |
| CB4613 | Withdrawn | |
| CB4L12R | Withdrawn | |
| CB4634 | Outer Diameter 12.7 mm | Withdrawn |
| CB3K76R | Withdrawn | |
| CB4623 | Withdrawn | |
| CB1351 | Withdrawn | |
| CB2F57R | Withdrawn | |
| CB4623 | Outer Diameter 9.5 mm | Withdrawn |
| CB4622 | Withdrawn | |
| CB4633 | Withdrawn | |
| CB4E96R5 | Withdrawn | |
| CB4630 | Withdrawn | |
| CB2994 | Withdrawn | |
| CB5U87R | Withdrawn | |
| CB4Z25R | Withdrawn | |
| CB2994 | 9.5 MM Port Outer Diameter | Withdrawn |
| CB2993 | Withdrawn | |
| CB5U80R | Withdrawn | |
| CB5U89R | Withdrawn | |
| CB2995 | Withdrawn | |
| CB4621 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | Medtronic, Inc. | 1,281 |
| Inspire | Sorin Group Italia SRL | 14 |
| Capiox®fx | Terumo Corp. | 14 |
| Capiox®rx | Terumo Corp. | 13 |
| Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U | Spectrum Medical Ltd | 11 |
| Lilliput | Sorin Group Italia SRL | 11 |
| Abiomed Breethe OXY-1 System | Breethe, Inc. | 11 |
| Kids | Sorin Group Italia SRL | 8 |
| Affinity NT™ | Medtronic, Inc. | 8 |
| Affinity Fusion™ | Medtronic, Inc. | 7 |
| QUADROX-i | Maquet Cardiopulmonary GmbH | 7 |
| Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. | Terumo Cardiovascular Systems Corporation | 6 |
Showing 12 of 69. All products under Oxygenator, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241352 | 2024-06-12 |
| K230640 | 2023-04-06 |
| K203111 | 2021-09-16 |
| K191444 | 2019-09-27 |
| K191029 | 2019-05-17 |
| K183490 | 2019-04-12 |
| K183511 | 2019-03-18 |
| K172984 | 2017-11-20 |
| K172626 | 2017-10-25 |
| K162896 | 2016-12-06 |
| K162016 | 2016-09-21 |
| K143073 | 2015-03-25 |
| K142784 | 2014-10-24 |
| K123314 | 2013-01-22 |
| K122827 | 2012-12-14 |
| K100645 | 2012-09-14 |
Recalls Naming This Product
8 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 | 2018-08-08 | Class II | Nonconforming Material/Component | Affected products failed a sterilization test. | 10 units | 2020-10-06 |
| Medtronic Perfusion Systems | 510(k) number | 2016-02-04 | Class III | Component design/selection | Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular | 9890 (7773 US, 2117 OUS) | 2016-11-07 |
| Medtronic, Inc. | 510(k) number | 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. | 217 | 2014-02-04 |
| Medtronic, Inc. | 510(k) number | 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 |
| Medtronic, Inc. | 510(k) number | 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 | 106 | 2014-05-22 |
| 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 | 311 US, 27 OUS | 2012-05-08 |
| Medtronic Perfusion Systems | 510(k) number | 2007-04-18 | Not classified | Other | Pyrogen Levels detected above specification: The product contains a pyrogen level above Medtronic”s internal specifications while the product is labeled as nonpyrogenic. | 11 units | 2007-11-01 |
| Medtronic, Inc. | 510(k) number | 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 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2016-11-16 | Class II | Process control | Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiot | 5609 (663 US; 4946 OUS) | 2017-08-01 |
| 2008-10-17 | Not classified | Error in labeling | Medtronic has identified an issue with the labeling of the I-4500 Silicone Oxygenators (P/N 61399402655). Lot numbers of this oxygenator manufactured between August 2007 and September 2008 have an incorrect “Recommended maximum blood flow | 408 | 2011-04-19 |
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.