510(k) K133681
K133681 is an FDA 510(k) premarket notification submitted by Volcano Corporation for the device "CRUX SNARE FILTER RETRIEVAL SET". The FDA issued a decision of Substantially Equivalent on January 30, 2014. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. Volcano Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2014
- Date Received
- December 2, 2013
- 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