The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Microvasive Insurg Chloangiographic Catheter.
Device ID | K932228 |
510k Number | K932228 |
Device Name: | MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER |
Classification | Catheter, Cholangiography |
Applicant | BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. San Jose, CA 95134 |
Contact | Sheri D O'brien |
Correspondent | Sheri D O'brien BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. San Jose, CA 95134 |
Product Code | GBZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-07 |
Decision Date | 1993-08-10 |