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 |