Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass
Venous Catheter, two-stage, SLIM, complete reinforcement, elliptic proximal body, Lighthouse tip, with connector
3manufacturers in China registered for this device type
135catalogue numbers in this listing
7510(k) clearances naming this product code
6recalls 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 | Maquet Cardiopulmonary GmbH, Germany |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K102532 |
| Record published | 2015-10-24 |
| Record revised | 2024-06-19 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, pack of 5 |
| Sizes | Catheter gauge 6 to 40 Fr; length 21.5 to 42 cm; angle 90 ° |
| Distribution end date | 2020-01-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Arterial HLS Cannula, Bioline coated | Catheter Gauge 15 Fr | In distribution |
| PIK 150 | OD Guidewire 0.038 Inch | In distribution |
| Arterial HLS Cannula, Bioline coated | Perforation length 1 Centimeter | In distribution |
| Venous HLS Cannula, Bioline coated | Catheter Gauge 25 Fr | In distribution |
| Venous HLS Cannula, uncoated | Insertion length 55 Centimeter | In distribution |
| Arterial HLS Cannula, uncoated | Perforation length 1 Centimeter | In distribution |
| Arterial HLS Cannula, uncoated | Perforation length 1 Centimeter | In distribution |
| Venous HLS Cannula, Bioline coated | Insertion length 55 Centimeter | In distribution |
| Venous HLS Cannula, Bioline coated | Perforation length 20 Centimeter | In distribution |
| Arterial HLS Cannula, uncoated | Connector 3/8 Inch with LL | In distribution |
| Arterial HLS Cannula, uncoated | Connector 3/8 Inch with LL | In distribution |
| Venous HLS Cannula, Bioline coated | Insertion length 55 Centimeter | In distribution |
| Venous HLS Cannula, Bioline coated | Connector 3/8 Inch | In distribution |
| Arterial HLS Cannula, uncoated | Catheter Gauge 13 Fr | In distribution |
| Arterial HLS Cannula, uncoated | Perforation length 1 Centimeter | In distribution |
| Arterial HLS Cannula, Bioline coated | Catheter Gauge 15 Fr | In distribution |
| Arterial HLS Cannula, Bioline coated | Insertion length 23 Centimeter | In distribution |
| PIK Dilator small | OD dilator 08/10 French | In distribution |
| Arterial HLS Cannula, Bioline coated | Catheter Gauge 23 Fr | In distribution |
| Arterial HLS Cannula, uncoated | Perforation length 1 Centimeter | In distribution |
| Venous HLS Cannula, uncoated | Connector 3/8 Inch | In distribution |
| Arterial HLS Cannula, Bioline coated | Perforation length 1 Centimeter | In distribution |
| Arterial HLS Cannula, uncoated | Perforation length 1 Centimeter | In distribution |
| Arterial HLS Cannula, Bioline coated | Perforation length 1 Centimeter | In distribution |
| Venous HLS Cannula, Bioline coated | Insertion length 55 Centimeter | In distribution |
| Arterial HLS Cannula, Bioline coated | Connector 3/8 Inch with LL | In distribution |
| Venous HLS Cannula, Bioline coated | Insertion length 38 Centimeter | In distribution |
| Venous HLS Cannula, uncoated | Insertion length 55 Centimeter | In distribution |
| Arterial HLS Cannula, uncoated | Connector 3/8 Inch with LL | In distribution |
| Venous HLS Cannula, uncoated | Insertion length 38 Centimeter | In distribution |
| PIK 100 | OD dilator 10/12 French | In distribution |
| Venous HLS Cannula, uncoated | Catheter Gauge 25 Fr | In distribution |
| Arterial HLS Cannula, Bioline coated | Perforation length 1 Centimeter | In distribution |
| Arterial HLS Cannula, uncoated | Catheter Gauge 21 Fr | In distribution |
| PIK dilator set large | OD dilator 22/24 French | In distribution |
| Arterial HLS Cannula, Bioline coated | Connector 3/8 Inch with LL | In distribution |
| Venous HLS Cannula, Bioline coated | Catheter Gauge 23 Fr | In distribution |
| Arterial HLS Cannula, Bioline coated | Insertion length 15 Centimeter | In distribution |
| Venous HLS Cannula, uncoated | Connector 3/8 Inch | In distribution |
| Venous HLS Cannula, uncoated | Connector 3/8 Inch | In distribution |
| Venous HLS Cannula, uncoated | Connector 3/8 Inch | In distribution |
| Arterial HLS Cannula, uncoated | Perforation length 1 Centimeter | In distribution |
| Art.Can.,reinf.,straight tip w.ring | Connection size 1/4 Inch | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,straight | connection size 3/8 inch | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,90° bent | Angle 90 ° | Withdrawn |
| Art.Can., reinf.,straight, with stylet | Length 21.5 cm | Withdrawn |
| Art.Can.,reinf.,straight tip w.ring | Connector with non-tip orientated LL 3/8 Inch | Withdrawn |
| Art.Can.,reinf.,straight tip w/o ring | Length 23 cm | Withdrawn |
| Art.Can.,reinf.,straight tip w/o ring | Catheter Gauge 14 Fr | Withdrawn |
| Ven.Cath.,reinf.,Pilot tip,90° bent | Tip length 2.5 Centimeter | Withdrawn |
| Ven.Cath.,reinf.,Pilot tip, straight | Length 25 cm | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,straight | Catheter Gauge 30 Fr | Withdrawn |
| Ven.Cath.,reinf.,Pilot tip,straight | Connection size 3/8 Inch | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,straight | Connection size 3/8 Inch | Withdrawn |
| Art.Can., reinf.,straight, with stylet | Length 21.5 cm | Withdrawn |
| Art.Can.,reinf.,curved tip w.ring | Catheter Gauge 20 Fr | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,straight | Length 40 cm | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,straight | Connection size 3/8 Inch | Withdrawn |
| Ven.Cath.,2-stage,reinf.,Bullet tip | Length 40 cm | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,90° bent | Tip length 7.0 Centimeter | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,straight | Length 40 cm | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip, 90° bent | Tip length 2.5 Centimeter | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,90° bent | Catheter Gauge 36 Fr | Withdrawn |
| Art.Can.,reinf.,curved tip w.flange | Length 23 cm | Withdrawn |
| Venous Catheter OD = 36 FR 3/8″ connection | Length 40 cm | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,90° bent | Catheter Gauge 16 Fr | Withdrawn |
| Art.Can.,reinf.,curved tip w.ring | Connection size 1/4 Inch | Withdrawn |
| Art.Can.,reinf.,curved tip w.ring | Length 23 cm | Withdrawn |
| Art.Can.,reinf.,curved tip w.ring | Catheter Gauge 8 Fr | Withdrawn |
| Art.Can., reinf.,straight, with stylet | Length 21.5 cm | Withdrawn |
| Art.Can.,reinf.,straight tip w/o ring | Connection size 1/4 Inch | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,90° bent | Angle 90 ° | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,90° bent | Tip length 5.0 Centimeter | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,90° bent | connection size 1/4 inch | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,straight | Length 40 cm | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,straight | Connection size 1/4 Inch | Withdrawn |
| Art.Can.,reinf.,straight tip w/o ring | Connection size 1/4 Inch | Withdrawn |
| Rigid sucker with mini-tip | Steel tube inner diameter 3.4 Millimeter | Withdrawn |
| Art.Can.,reinf.,curved tip w.ring | Connection size 1/4 Inch | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,straight | Catheter Gauge 18 Fr | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,90° bent | Catheter Gauge 16 Fr | Withdrawn |
| Art.Can.,reinf.,straight tip w.ring | Length 23 cm | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,straight | Connection size 1/4 Inch | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,straight | Catheter Gauge 32 Fr | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,90° bent | Length 40 cm | Withdrawn |
| Art.Can.,reinf.,curved tip w.flange | Connector 3/8 Inch | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,straight | Catheter Gauge 32 Fr | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,straight | connection size 1/4 inch | Withdrawn |
| Ven.Cath.,2-stage,reinf.,Bullet tip | Length distal part 9 Centimeter | Withdrawn |
| Art.Can.,reinf.,curved tip w.flange | Connection size 3/8 Inch | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,straight | connection size 3/8 inch | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,straight | Connection size 1/4 Inch | Withdrawn |
| Art.Can.,reinf.,curved tip w.ring | Length 23 cm | Withdrawn |
| Ven.Cath.,2-stage,reinf.,Light.tip,bent | Outer Diameter 32/40 French | Withdrawn |
| Art.Can., reinf.,straight, with stylet | Length 21.5 cm | Withdrawn |
| Ven.Cath.,reinf.,Pilot tip,90° bent | connection size 1/4 inch | Withdrawn |
| Art.Can.,reinf.,curved tip w.ring | Connection size 3/8 Inch | Withdrawn |
| Art.Can.,reinf.,straight tip w.ring | Length 23 cm | Withdrawn |
| Art.Can., reinf.,straight, with stylet | Catheter Gauge 8 Fr | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,straight | Length 22 cm | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,90° bent | Tip length 3.0 Centimeter | Withdrawn |
| Art.Can.,reinf.,curved tip w.flange | Connector with tip orientated LL 3/8 Inch | Withdrawn |
| Art.Can., reinf.,straight, with stylet | Length 21.5 cm | Withdrawn |
| Art.Can.,reinf.,straight tip w.flange | Length 23 cm | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,straight | Catheter Gauge 12 Fr | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,90° bent | Tip length 5.0 Centimeter | Withdrawn |
| Art.Can.,reinf.,curved tip w.ring | Length 23 cm | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,90° bent | Tip length 2.5 Centimeter | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,straight | Catheter Gauge 20 Fr | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,90° bent | Angle 90 ° | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,90° bent | Angle 90 ° | Withdrawn |
| Art.Can., reinf.,straight, with stylet | Catheter Gauge 10 Fr | Withdrawn |
| Art.Can.,reinf.,straight tip w.ring | Catheter Gauge 8 Fr | Withdrawn |
| Ven.Cath.,reinf.,90° bent,Bullet tip | Length 40 cm | Withdrawn |
| Art.Can.,reinf.,straight tip w.flange | Catheter Gauge 22 Fr | Withdrawn |
| Ven.Cath.,2-stage,reinf.,Bullet tip | Length 40 cm | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,90° bent | Catheter Gauge 36 Fr | Withdrawn |
| Ven.Cath.,2-stage,reinf.,Bullet tip | Length 40 cm | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,straight | Length 40 cm | Withdrawn |
| Ven.Cath.,2-stage,reinf.,Basket tip | Length distal part 7.5 Centimeter | Withdrawn |
| Ven.Cath.,2-stage,reinf.,Bullet tip | Outer Diameter 32/40 French | Withdrawn |
| Ven.Cath.,reinf.,Lighthouse tip,90° bent | connection size 3/8 inch | Withdrawn |
| Ven.Cath.,2-stage,reinf.,ell.,Light.tip | Outer Diameter 32/40 French | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,90° bent | Tip length 2.5 Centimeter | Withdrawn |
| Ven.Cath.,reinf.,Bullet tip,90° bent | Length 40 cm | Withdrawn |
| Rigid sucker | Length 34 cm | Withdrawn |
| Ven.Cath.,reinf.,Pilot tip,90° bent | Tip length 3.0 Centimeter | Withdrawn |
| Pericardial sump sucker | Length 35 cm | Withdrawn |
| Art.Can., reinf.,straight, with stylet | Catheter Gauge 6 Fr | Withdrawn |
| Art.Can.,reinf.,curved tip w.flange | Connection size 3/8 Inch | Withdrawn |
| Art.Can.,reinf.,straight tip w/o ring | Length 23 cm | Withdrawn |
| Art.Can.,reinf.,curved tip w.flange | Catheter Gauge 20 Fr | Withdrawn |
| Malleable sucker | Tip outer diamteter 21 French | Withdrawn |
| Ven.Cath.,reinf.,Pilot tip,straight | Connection size 1/4 Inch | Withdrawn |
| Art.Can.,reinf.,straight tip w.ring | Catheter Gauge 16 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic, Inc. | 5,237 |
| DLP™ | Medtronic, Inc. | 804 |
| Bio-Medicus™ | Medtronic, Inc. | 223 |
| Pemco Inc | Pemco, Inc. | 137 |
| 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 |
|---|---|
| K140569 | 2014-11-19 |
| K131666 | 2013-07-05 |
| K130639 | 2013-05-16 |
| K102532 | 2011-02-25 |
| K090533 | 2009-12-18 |
| K072172 | 2007-08-31 |
| K061832 | 2006-08-11 |
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|---|
| Maquet Cardiopulmonary GmbH | 510(k) number | 2026-07-31 | Not classified | Packaging | The packaging may not consistently maintain sterile barrier integrity. | 68371 units (1765 US, 66606 OUS) | |
| Maquet Cardiopulmonary GmbH | 510(k) number | 2026-07-31 | Not classified | Packaging | The packaging may not consistently maintain sterile barrier integrity. | 185617 units (5926 US, 179691 OUS) | |
| Maquet Cardiopulmonary GmbH | 510(k) number | 2026-07-31 | Not classified | Packaging | The packaging may not consistently maintain sterile barrier integrity. | 16697 units (492 USA, 16205 OUS) | |
| Maquet Cardiopulmonary GmbH | 510(k) number | 2018-05-14 | Class II | Component design/selection | This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. | 40 US | 2020-05-15 |
| Maquet Cardiopulmonary GmbH | 510(k) number | 2018-05-14 | Class II | Component design/selection | This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. | 470 US | 2020-05-15 |
| Maquet Cardiopulmonary GmbH | 510(k) number | 2018-05-14 | Class II | Component design/selection | This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. | 150 US | 2020-05-15 |
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.