The Carpentier Trans-Mitral Ventricular Vent(Tm)
FDA 510(k) K883412 · Promedica Products, Inc.
510(k) numberK883412
Submission
- Device name
- The Carpentier Trans-Mitral Ventricular Vent(Tm)
- Applicant
- Promedica Products, Inc.
Newport Beach, CA, US - Received
- August 15, 1988
- Decision date
- February 8, 1989
- 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
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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 |
|---|---|---|
| K913101 | Peters Cardioflon(Tm) SutureGAS · Traditional | 08/12/1992SE |
| K913102 | Peters Cardionyl(Tm) SutureGAR · Traditional | 08/03/1992SE |
| K892768 | Patient Examination Gloves (Poly)LZA · Traditional | 06/14/1989SE |
| K882883 | C-Mask(Flat)FXX · Traditional | 08/10/1988SE |
| K882882 | C-MaskFXX · Traditional | 08/10/1988SE |
Questions and answers
When was The Carpentier Trans-Mitral Ventricular Vent(Tm) cleared by the FDA?
The Carpentier Trans-Mitral Ventricular Vent(Tm) (K883412) received a 510(k) decision of Substantially Equivalent on February 8, 1989, 177 days after the submission was received.
What is the product code of K883412?
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.