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 |