510(k) K791130
K791130 is an FDA 510(k) premarket notification submitted by Venospital, Inc. for the device "FLU-VEN TK-2". The FDA issued a decision of Substantially Equivalent on September 4, 1979. The device falls under product code KSB (Set, Transfer (Blood/Plasma)), a Class II device regulated under 21 CFR 864.9875. Venospital, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 1979
- Date Received
- June 18, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Transfer (Blood/Plasma)
- Device Class
- Class II
- Regulation Number
- 864.9875
- Review Panel
- HE
- Submission Type