The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Code #94315 Retrograde Coronary Sinus Perf Cannula.
| Device ID | K901074 |
| 510k Number | K901074 |
| Device Name: | CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | A Williams |
| Correspondent | A Williams DLP, INC. P.O.BOX 409 620 WATSONS S.W. 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 | 1990-03-08 |
| Decision Date | 1990-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994582427 | K901074 | 000 |
| 20613994575528 | K901074 | 000 |
| 20613994575573 | K901074 | 000 |
| 20613994575610 | K901074 | 000 |
| 20613994575641 | K901074 | 000 |
| 20613994575665 | K901074 | 000 |
| 20613994575689 | K901074 | 000 |
| 20613994575771 | K901074 | 000 |
| 20613994575795 | K901074 | 000 |
| 20613994575818 | K901074 | 000 |
| 20613994575832 | K901074 | 000 |
| 20613994575887 | K901074 | 000 |
| 20613994575504 | K901074 | 000 |