510(k) K873894
K873894 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE". The FDA issued a decision of Substantially Equivalent on November 5, 1987. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1987
- Date Received
- September 24, 1987
- 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