The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Acuity Pro Lead Delivery System.
| Device ID | K171612 |
| 510k Number | K171612 |
| Device Name: | ACUITY Pro Lead Delivery System |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-01 |
| Decision Date | 2017-06-30 |
| Summary: | summary |