510(k) K854965
K854965 is an FDA 510(k) premarket notification submitted by Rao Medical Devices, Inc. for the device "IN LINE VALVE CATALOG NO. 2000A". The FDA issued a decision of Substantially Equivalent on February 21, 1986. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Rao Medical Devices, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1986
- Date Received
- December 11, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type