CPC, Couble Lumen Cardioplegia-Air Aspi
FDA 510(k) K832124 · Med-West, Inc.
510(k) numberK832124
Submission
- Device name
- CPC, Couble Lumen Cardioplegia-Air Aspi
- Applicant
- Med-West, Inc.
Walker, MI, US - Received
- June 30, 1983
- Decision date
- August 12, 1983
- 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 |
|---|---|---|
| K880877 | Contrast Injection DeviceDXT · Traditional | 05/31/1988SE |
| K880398 | Power Toilet ElevatorINO · Traditional | 03/17/1988SE |
| K874470 | Mwi 400 Wound DressingNAD · Traditional | 12/18/1987SN |
| K872724 | Sheath/DilatorsDRE · Traditional | 09/15/1987SE |
| K854612 | Acute Hemodialysis Tray, CAT.#09-9540-7LFK · Traditional | 01/03/1986SESD |
| K852162 | Mni 400 Injection CapsLFJ · Traditional | 06/12/1985SE |
| K842342 | Mwi 888 & 666 Double Lumen Subclavian · Traditional | 06/14/1984SESP |
| K831828 | Teflon Femoral Catheter Mwi 100,10 &LFK · Traditional | 07/07/1983SE |
| K831440 | Single Needle Subclavian Vein MWI250/260FIQ · Traditional | 06/03/1983SE |
| K831401 | Single Needle Subclavian Vein AccessFIQ · Traditional | 06/03/1983SE |
Questions and answers
When was CPC, Couble Lumen Cardioplegia-Air Aspi cleared by the FDA?
CPC, Couble Lumen Cardioplegia-Air Aspi (K832124) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 43 days after the submission was received.
What is the product code of K832124?
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.