510(k) K834448

URINARY DRAINAGE CONTAINER by Vital Metrics, Inc. — Product Code KNX

K834448 is an FDA 510(k) premarket notification submitted by Vital Metrics, Inc. for the device "URINARY DRAINAGE CONTAINER". The FDA issued a decision of Substantially Equivalent on February 10, 1984. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Vital Metrics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1984
Date Received
December 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type