510(k) K854346

MEDIFLEX DISPOSABLE TUBING CLAMP by Mediflex Intl. — Product Code FPA

K854346 is an FDA 510(k) premarket notification submitted by Mediflex Intl. for the device "MEDIFLEX DISPOSABLE TUBING CLAMP". The FDA issued a decision of Substantially Equivalent on November 18, 1985. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Mediflex Intl. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1985
Date Received
October 29, 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