The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Microvasive Extractor, Retrieval Balloon Catheter.
| Device ID | K931619 |
| 510k Number | K931619 |
| Device Name: | MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| 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 | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-02 |
| Decision Date | 1993-08-20 |