Softip Coronary Sinus Cardioplegia Catheter
FDA 510(k) K863342 · Angiomedics, Inc.
510(k) numberK863342
Submission
- Device name
- Softip Coronary Sinus Cardioplegia Catheter
- Applicant
- Angiomedics, Inc.
Minneapolis, MN, US - Received
- August 28, 1986
- Decision date
- March 3, 1987
- 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 |
|---|---|---|
| K873195 | Schneider-Shiley Angioport(Tm) Ptca Intro W/HemoDYB · Traditional | 12/15/1987SE |
| K872542 | Schneider-Shiley Softrac-Pta(Tm) Angio. CatheterLIT · Traditional | 09/14/1987SE |
| K872472 | Schneider-Shiley Biflator Balloon Inflation DeviceDXT · Traditional | 09/14/1987SE |
| K861238 | Angiomedics Cath Sheath Introduc W/Hemostasis ValvDYB · Traditional | 07/16/1986SE |
| K852872 | Angiomedics Softip CatheterDQO · Traditional | 10/11/1985SE |
| K850271 | Angiomedic's Catheter-Diagnostic IntravascularDQO · Traditional | 04/03/1985SE |
| K834275 | Softip CatheterDQO · Traditional | 02/04/1984SE |
Questions and answers
When was Softip Coronary Sinus Cardioplegia Catheter cleared by the FDA?
Softip Coronary Sinus Cardioplegia Catheter (K863342) received a 510(k) decision of Substantially Equivalent on March 3, 1987, 187 days after the submission was received.
What is the product code of K863342?
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.