The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Cardiopulminary Bypass Catheter Cannula.
Device ID | K810548 |
510k Number | K810548 |
Device Name: | CARDIOPULMINARY BYPASS CATHETER CANNULA |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | DLP, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-02 |
Decision Date | 1981-03-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613994374899 | K810548 | 000 |
20613994495505 | K810548 | 000 |
20613994495444 | K810548 | 000 |
20613994495406 | K810548 | 000 |
20613994495390 | K810548 | 000 |
20613994495383 | K810548 | 000 |
20613994495352 | K810548 | 000 |
20613994495338 | K810548 | 000 |
20613994495321 | K810548 | 000 |
20613994495307 | K810548 | 000 |
20613994495529 | K810548 | 000 |
20613994495543 | K810548 | 000 |
00643169695948 | K810548 | 000 |
00673978861579 | K810548 | 000 |
00673978861562 | K810548 | 000 |
00673978861555 | K810548 | 000 |
20613994736691 | K810548 | 000 |
20613994736677 | K810548 | 000 |
20613994495666 | K810548 | 000 |
20613994495574 | K810548 | 000 |
20613994495550 | K810548 | 000 |
00763000192419 | K810548 | 000 |