The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Boston Scientific Ultra-soft Sv Balloon Dilatation Catheter.
| Device ID | K021735 |
| 510k Number | K021735 |
| Device Name: | BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Candice Burns |
| Correspondent | Candice Burns BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-28 |
| Decision Date | 2002-08-08 |
| Summary: | summary |