The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for First Midcath Catheter With Dual Lumens.
Device ID | K964049 |
510k Number | K964049 |
Device Name: | FIRST MIDCATH CATHETER WITH DUAL LUMENS |
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 | 1996-10-09 |
Decision Date | 1997-01-06 |
Summary: | summary |