The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Morse(r) Angiographic Catheters.
Device ID | K922552 |
510k Number | K922552 |
Device Name: | MORSE(R) ANGIOGRAPHIC CATHETERS |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
Contact | Meager Rubin |
Correspondent | Meager Rubin NORTH AMERICAN INSTRUMENT CORP. 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 | 1992-05-29 |
Decision Date | 1993-03-03 |