The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Watchdog Hemostasis Valve Kit.
| Device ID | K172453 |
| 510k Number | K172453 |
| Device Name: | WATCHDOG Hemostasis Valve Kit |
| Classification | Wire, Guide, Catheter |
| Applicant | Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 -1566 |
| Contact | Lori Berends |
| Correspondent | Lori Berends Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 -1566 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-14 |
| Decision Date | 2017-11-09 |