The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Angiographic Catheter, Model Angios.
Device ID | K092118 |
510k Number | K092118 |
Device Name: | ANGIOGRAPHIC CATHETER, MODEL ANGIOS |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
Contact | Mila Doskocil |
Correspondent | Mila Doskocil Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-14 |
Decision Date | 2010-01-13 |