510(k) K980016
K980016 is an FDA 510(k) premarket notification submitted by Genzyme Surgical Product (Genzyme Biosurgery) for the device "MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE". The FDA issued a decision of Substantially Equivalent on August 7, 1998. The device falls under product code MOP (Rotator, Prosthetic Heart Valve), a Class I device regulated under 21 CFR 870.3935. Genzyme Surgical Product (Genzyme Biosurgery) has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1998
- Date Received
- January 2, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rotator, Prosthetic Heart Valve
- Device Class
- Class I
- Regulation Number
- 870.3935
- Review Panel
- CV
- Submission Type