Cardioplegia Solution Admin. Set
FDA 510(k) K792152 · Cardio Systems, Inc.
510(k) numberK792152
Submission
- Device name
- Cardioplegia Solution Admin. Set
- Applicant
- Cardio Systems, Inc.
Mchenry, IL, US - Received
- October 22, 1979
- Decision date
- November 13, 1979
- 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 |
|---|---|---|
| K131092 | Stealth 360 Orbital Pad SystemMCW · Special | 06/24/2013SE |
| K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy SystemMCW · Special | 08/14/2008SE |
| K972022 | ZAK-2000FNM · Traditional | 01/22/1998SE |
| K934689 | Low Air Loss Mattress, ModificationINX · Traditional | 02/02/1994SE |
| K921500 | Centri-Safe(Tm) ValveMJJ · Traditional | 09/15/1992SE |
| K882177 | Add-On to Critical Patient Care BedIOQ · Traditional | 12/01/1988SE |
| K852736 | Baylor Rapid Autotransfusion SystemCAC · Traditional | 09/18/1985SE |
| K792151 | Oxygenator Gas Line FilterKRI · Traditional | 11/13/1979SE |
Questions and answers
When was Cardioplegia Solution Admin. Set cleared by the FDA?
Cardioplegia Solution Admin. Set (K792152) received a 510(k) decision of Substantially Equivalent on November 13, 1979, 22 days after the submission was received.
What is the product code of K792152?
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.