The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Usci Angiographic Catheter.
Device ID | K932092 |
510k Number | K932092 |
Device Name: | USCI ANGIOGRAPHIC CATHETER |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
Contact | Beth Rochette |
Correspondent | Beth Rochette C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-30 |
Decision Date | 1993-07-29 |