The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for New Model Styles For Aortic Arch Cannula.
| Device ID | K870825 |
| 510k Number | K870825 |
| Device Name: | NEW MODEL STYLES FOR AORTIC ARCH CANNULA |
| Classification | Cannula, Catheter |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Morton Barak |
| Correspondent | Morton Barak SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | DQR |
| CFR Regulation Number | 870.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178002470 | K870825 | 000 |
| 38033178002180 | K870825 | 000 |
| 38033178001534 | K870825 | 000 |
| 38033178001527 | K870825 | 000 |
| 38033178001510 | K870825 | 000 |
| 38033178001411 | K870825 | 000 |
| 38033178001398 | K870825 | 000 |
| 38033178001381 | K870825 | 000 |
| 38033178001374 | K870825 | 000 |
| 38033178002289 | K870825 | 000 |
| 38033178002296 | K870825 | 000 |
| 38033178002302 | K870825 | 000 |
| 38033178002463 | K870825 | 000 |
| 38033178002456 | K870825 | 000 |
| 38033178002449 | K870825 | 000 |
| 38033178002432 | K870825 | 000 |
| 38033178002425 | K870825 | 000 |
| 38033178002333 | K870825 | 000 |
| 38033178002326 | K870825 | 000 |
| 38033178002319 | K870825 | 000 |
| 38033178001244 | K870825 | 000 |