The following data is part of a premarket notification filed by North Coast Medi-tek with the FDA for Ivr-sp Custom Angiography Tray.
| Device ID | K870419 |
| 510k Number | K870419 |
| Device Name: | IVR-SP CUSTOM ANGIOGRAPHY TRAY |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | NORTH COAST MEDI-TEK 8603 EAST AVE. Mentor, OH 44060 |
| Contact | Theresa Sokolowski |
| Correspondent | Theresa Sokolowski NORTH COAST MEDI-TEK 8603 EAST AVE. Mentor, OH 44060 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-05-11 |