The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Introducer Sheaths, Vessel Dilator, Guidewire.
| Device ID | K994252 |
| 510k Number | K994252 |
| Device Name: | INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE |
| Classification | Introducer, Catheter |
| Applicant | BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Contact | Andrea Boumis |
| Correspondent | Andrea Boumis BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-17 |
| Decision Date | 2000-01-04 |
| Summary: | summary |