The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Arterial Perfusion Cannula.
| Device ID | K894243 |
| 510k Number | K894243 |
| Device Name: | RMI ARTERIAL PERFUSION CANNULA |
| Classification | Cannula, Catheter |
| Applicant | RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City, UT 84119 |
| Contact | Michael Kelly |
| Correspondent | Michael Kelly RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City, UT 84119 |
| Product Code | DQR |
| CFR Regulation Number | 870.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-21 |
| Decision Date | 1989-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103026399 | K894243 | 000 |
| 00690103026382 | K894243 | 000 |
| 00690103026375 | K894243 | 000 |
| 00690103026368 | K894243 | 000 |
| 00690103026351 | K894243 | 000 |
| 00690103026344 | K894243 | 000 |