510(k) K854941

PMS PERCUTANEOUS PUNCTURE NEEDLE by Professional Medical Services — Product Code DYB

K854941 is an FDA 510(k) premarket notification submitted by Professional Medical Services for the device "PMS PERCUTANEOUS PUNCTURE NEEDLE". The FDA issued a decision of Substantially Equivalent on April 16, 1986. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Professional Medical Services has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1986
Date Received
December 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type