510(k) K142461
K142461 is an FDA 510(k) premarket notification submitted by Synovis Life Technologies, Inc. for the device "VASCU-GUARD Peripheral Vascular Patch". The FDA issued a decision of Substantially Equivalent on November 25, 2014. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Synovis Life Technologies, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 2014
- Date Received
- September 2, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Device Class
- Class II
- Regulation Number
- 870.3470
- Review Panel
- CV
- Submission Type