The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Retrograde Coronary Sinus Perfusion Cannula With Elongated & Treaded Cuff & Introducer Stylet.
| Device ID | K953945 |
| 510k Number | K953945 |
| Device Name: | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
| Contact | Roger W Brink |
| Correspondent | Roger W Brink DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-21 |
| Decision Date | 1996-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169454846 | K953945 | 000 |
| 20613994625629 | K953945 | 000 |
| 20613994625643 | K953945 | 000 |
| 20613994625667 | K953945 | 000 |
| 20613994625681 | K953945 | 000 |
| 20643169454457 | K953945 | 000 |
| 20643169454464 | K953945 | 000 |
| 20643169454679 | K953945 | 000 |
| 20643169454686 | K953945 | 000 |
| 20643169454693 | K953945 | 000 |
| 20643169454709 | K953945 | 000 |
| 20643169454778 | K953945 | 000 |
| 20643169454785 | K953945 | 000 |
| 20643169454792 | K953945 | 000 |
| 20643169454808 | K953945 | 000 |
| 20643169454815 | K953945 | 000 |
| 20643169454822 | K953945 | 000 |
| 20643169454839 | K953945 | 000 |
| 20613994625605 | K953945 | 000 |