The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Selector Angiographic Catheter (various Models).
| Device ID | K960801 |
| 510k Number | K960801 |
| Device Name: | SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS) |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | NORTH AMERICAN INSTRUMENT CORP. PRUYNS ISLAND RD. Glens Falls, NY 12801 |
| Contact | Mary Meagher Rubin |
| Correspondent | Mary Meagher Rubin NORTH AMERICAN INSTRUMENT CORP. PRUYNS ISLAND RD. Glens Falls, NY 12801 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-27 |
| Decision Date | 1996-03-29 |
| Summary: | summary |