510(k) K950301

ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS by Becton Dickinson Vascular Access, Inc. — Product Code FOZ

K950301 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vascular Access, Inc. for the device "ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS". The FDA issued a decision of Substantially Equivalent on April 18, 1995. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Becton Dickinson Vascular Access, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1995
Date Received
January 25, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type