510(k) K954906

FIRST PICC INTRODUCER CATHETER by Becton Dickinson Vascular Access, Inc. — Product Code DYB

K954906 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vascular Access, Inc. for the device "FIRST PICC INTRODUCER CATHETER". The FDA issued a decision of Substantially Equivalent on April 8, 1996. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Becton Dickinson Vascular Access, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1996
Date Received
October 25, 1995
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