The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for Angiocath(r) Nonvalon(r) And Angio-set(r) Iv Catheters.
Device ID | K950301 |
510k Number | K950301 |
Device Name: | ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Contact | C J Welle |
Correspondent | C J Welle BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-25 |
Decision Date | 1995-04-18 |