510(k) K791792
K791792 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCI MED PERICARDIAL SUBSTITUTE". The FDA issued a decision of Substantially Equivalent on Dec 7, 1979. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 7, 1979
- Date Received
- Sep 13, 1979
- 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
- 510(k)