Elite-I (Bi) Dual Lumen Catheter; Elite-I (Ra) Dual Lumen Catheter; Elite-I (Bix)Dual Lumen Catheter
FDA 510(k) K130639 · Maquet Cardiopulmonary, AG
510(k) numberK130639
Submission
- Device name
- Elite-I (Bi) Dual Lumen Catheter; Elite-I (Ra) Dual Lumen Catheter; Elite-I (Bix)Dual Lumen Catheter
- Applicant
- Maquet Cardiopulmonary, AG
Rastatt De-Bw, DE - Received
- March 11, 2013
- Decision date
- May 16, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4210
- Specialty
- Cardiovascular
Other 510(k)s with product code DWF
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|---|---|---|---|
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial CannulaeDWF · Special | Medtronic, Inc. | 04/23/2026SE |
| K250937 | Venous Return CannulaeDWF · Traditional | LivaNova USA, Inc. | 03/11/2026SE |
| K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)DWF · Traditional | Smart Reactors | 02/23/2026SE |
| K253203 | Retrograde Coronary Sinus Perfusion CannulaeDWF · Traditional | Medtronic, Inc. | 02/19/2026SE |
| K253671 | Dual Stage Venous CannulaeDWF · Traditional | Sorin Group Italia S.R.L. | 01/30/2026SE |
| K253998 | Clearview Intracoronary ShuntsDWF · Special | Medtronic, Inc. | 01/20/2026SE |
| K253106 | AngioVac CannulaDWF · Special | AngioDynamics, Inc. | 10/24/2025SE |
| K250283 | RAP Femoral Venous CannulaeDWF · Special | LivaNova USA, Inc. | 07/10/2025SE |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)DWF · Special | Sorin Group Italia S.R.L. | 06/27/2025SE |
| K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous CannulaDWF · Traditional | Medtronic, Inc. | 06/20/2025SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsDTZ · Traditional | 05/07/2015SE |
| K140569 | Antegrade Cardioplegia Cannula(N-Type)DWF · Traditional | 11/19/2014SE |
| K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…DTN · Special | 07/07/2014SE |
| K133598 | Cardiohelp SystemDTQ · Traditional | 05/21/2014SE |
| K133265 | Quadrox-Ir Adult and Small AdultKFM · Special | 11/12/2013SE |
| K132166 | Venous Hardshell Cardiotomy Reservoir; Non-Coated, Non-Tight/ Vacuum-Tight/ with…DTN · Special | 10/30/2013SE |
| K132829 | Quadrox-I, Quadrox-Id, Quadrox-Ir OxygenatorsDTZ · Special | 10/08/2013SE |
| K131666 | Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingDWF · Special | 07/05/2013SE |
| K130300 | Heater-Cooler Unit Hcu 40DWC · Traditional | 07/01/2013SE |
| K123288 | HemoconcentratorKDI · Traditional | 06/26/2013SE |
Questions and answers
When was Elite-I (Bi) Dual Lumen Catheter; Elite-I (Ra) Dual Lumen Catheter; Elite-I (Bix)Dual Lumen Catheter cleared by the FDA?
Elite-I (Bi) Dual Lumen Catheter; Elite-I (Ra) Dual Lumen Catheter; Elite-I (Bix)Dual Lumen Catheter (K130639) received a 510(k) decision of Substantially Equivalent on May 16, 2013, 66 days after the submission was received.
What is the product code of K130639?
The FDA product code is DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4210.