510(k) K853313
K853313 is an FDA 510(k) premarket notification submitted by Hemex Scientific, Inc. for the device "DUROMEDICS CARDIAC VALVE SIZER SET". The FDA issued a decision of Substantially Equivalent on November 1, 1985. The device falls under product code DTI (Sizer, Heart-Valve, Prosthesis), a Class I device regulated under 21 CFR 870.3945.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 1985
- Date Received
- August 7, 1985
- 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