Submission Details
| 510(k) Number | K953945 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 21, 1995 |
| Decision Date | March 26, 1996 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
K953945 - RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET
(FDA 510(k) Clearance)
Mar 1996
Decision
218d
Days
Class 2
Risk
K953945 is an FDA 510(k) clearance for the RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on March 26, 1996, 218 days after receiving the submission on August 21, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.
Device Classification
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4210 |
Similar Devices — DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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