510(k) K171612
K171612 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "ACUITY Pro Lead Delivery System". The FDA issued a decision of Substantially Equivalent on Jun 30, 2017. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Boston Scientific Corporation has 238 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 30, 2017
- Date Received
- Jun 1, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)