510(k) K163307
K163307 is an FDA 510(k) premarket notification submitted by Vascular Solutions, Inc. for the device "Expro Elite Snare, Sympro Elite Snare". The FDA issued a decision of Substantially Equivalent on March 8, 2017. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. Vascular Solutions, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2017
- Date Received
- November 23, 2016
- 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