Polystan Two Stage Catheters
FDA 510(k) K874853 · Polystan C/O Vitalcor, Inc.
510(k) numberK874853
Submission
- Device name
- Polystan Two Stage Catheters
- Applicant
- Polystan C/O Vitalcor, Inc.
Westmont, IL, US - Received
- November 25, 1987
- Decision date
- February 5, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K894657 | Polystan Heart-Lung Machine SystemDJQ · Traditional | 03/28/1990SE |
| K893940 | Polystan Heater-Cooler UnitDWC · Traditional | 01/18/1990SE |
| K893705 | SAFE-1 Venous ReservoirDTN · Traditional | 12/22/1989SE |
| K893704 | SAFE-1DTZ · Traditional | 12/22/1989SE |
| K874852 | Polystan Wire Reinforced Two Stage CathetersDWF · Traditional | 02/05/1988SE |
| K872182 | Polystan Wire Reinforced Catheters and CannulaeDQY · Traditional | 10/30/1987SE |
| K843538 | Po 2 LytrodeDRY · Traditional | 10/18/1984SE |
Questions and answers
When was Polystan Two Stage Catheters cleared by the FDA?
Polystan Two Stage Catheters (K874853) received a 510(k) decision of Substantially Equivalent on February 5, 1988, 72 days after the submission was received.
What is the product code of K874853?
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.