The following data is part of a premarket notification filed by Boston Scientific with the FDA for Watchman Truseal Access System.
| Device ID | K180864 |
| 510k Number | K180864 |
| Device Name: | WATCHMAN TruSeal Access System |
| Classification | Catheter, Percutaneous |
| Applicant | Boston Scientific Three Scimed Place Maple Grove, MN 55311 -1566 |
| Contact | Nikki M Ibis |
| Correspondent | Nikki M Ibis Boston Scientific Three Scimed Place Maple Grove, MN 55311 -1566 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-02 |
| Decision Date | 2018-07-20 |
| Summary: | summary |