510(k) K971726
K971726 is an FDA 510(k) premarket notification submitted by Bio-Vascular, Inc. for the device "CV PERI-GUARD - CARDIOVASCULAR PATCH". The FDA issued a decision of Substantially Equivalent on April 10, 1998. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Bio-Vascular, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1998
- Date Received
- May 9, 1997
- 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