510(k) K910378

PRESSURE MONITORING EXTENSION LINE by Professional Medical Services — Product Code DQO

K910378 is an FDA 510(k) premarket notification submitted by Professional Medical Services for the device "PRESSURE MONITORING EXTENSION LINE". The FDA issued a decision of Substantially Equivalent on April 22, 1991. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Professional Medical Services has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1991
Date Received
January 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type