Remote Access Perfusion (Rap) Femoral Venous Cannula
FDA 510(k) K052081 · Estech, Inc.
510(k) numberK052081
Submission
- Device name
- Remote Access Perfusion (Rap) Femoral Venous Cannula
- Applicant
- Estech, Inc.
Alameda, CA, US - Received
- August 2, 2005
- Decision date
- December 16, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K133017 | Estech Cobra(R) Genesis Bipolar ClampGEI · Special | 10/07/2013SE |
| K053021 | Estech Clearview MV Atrial DepressorDTS · Traditional | 01/26/2006SE |
| K051749 | Cobra Surgical SystemGEI · Traditional | 09/13/2005SE |
| K041599 | Cobra Adhere Surgical SystemGEI · Traditional | 07/27/2004SE |
| K032632 | Remote Access Perfusion Cannula Left Axillary 21 FrenchDWF · Abbreviated | 10/22/2003SE |
| K990573 | Estech Arterial Remote Access Perfusion CannulaDXC · Traditional | 03/11/1999SE |
Questions and answers
When was Remote Access Perfusion (Rap) Femoral Venous Cannula cleared by the FDA?
Remote Access Perfusion (Rap) Femoral Venous Cannula (K052081) received a 510(k) decision of Substantially Equivalent on December 16, 2005, 136 days after the submission was received.
What is the product code of K052081?
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.