Stockert A272 Series Pediatric Aortic Cannulae
FDA 510(k) K002273 · Stoeckert Instrumente
510(k) numberK002273
Submission
- Device name
- Stockert A272 Series Pediatric Aortic Cannulae
- Applicant
- Stoeckert Instrumente
Arvada, CO, US - Received
- July 26, 2000
- Decision date
- January 29, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K001961 | Stockert A242 and A252 Series Arterial Femoral CannulaeDWF · Abbreviated | 01/25/2001SE |
| K002118 | Stockert Compact System Version 2.0DTQ · Special | 08/09/2000SE |
| K992635 | Interface Module IdddKRI · Special | 12/20/1999SE |
| K990512 | Stockert Power Supply Unit for S3 ComponentsKRI · Traditional | 11/23/1999SE |
| K982014 | Stockert Compact SystemDTQ · Special | 09/04/1998SE |
| K972321 | S3 Mast PumpDWB · Traditional | 02/27/1998SE |
| K971520 | S3 Cyclic RPM ControlDWB · Traditional | 09/10/1997SE |
| K962320 | S3 Cardioplegia ControlDTR · Traditional | 01/10/1997SE |
| K955152 | Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. Ctrl., Temp Mont., TimerDTW · Traditional | 02/22/1996SE |
| K955038 | Stockert S3 Double Head Pump ModuleDWB · Traditional | 02/21/1996SE |
Questions and answers
When was Stockert A272 Series Pediatric Aortic Cannulae cleared by the FDA?
Stockert A272 Series Pediatric Aortic Cannulae (K002273) received a 510(k) decision of Substantially Equivalent on January 29, 2001, 187 days after the submission was received.
What is the product code of K002273?
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.