510(k) K881279
K881279 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET". The FDA issued a decision of Substantially Equivalent on May 18, 1988. The device falls under product code DTI (Sizer, Heart-Valve, Prosthesis), a Class I device regulated under 21 CFR 870.3945. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 1988
- Date Received
- March 22, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sizer, Heart-Valve, Prosthesis
- Device Class
- Class I
- Regulation Number
- 870.3945
- Review Panel
- CV
- Submission Type