510(k) K170987
K170987 is an FDA 510(k) premarket notification submitted by Avantec Vascular Corporation for the device "Captus Vascular Retrieval System". The FDA issued a decision of Substantially Equivalent on August 28, 2017. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. Avantec Vascular Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2017
- Date Received
- April 3, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Percutaneous Retrieval
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type