The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems, Inc. with the FDA for First Midcath Catheter.
Device ID | K972254 |
510k Number | K972254 |
Device Name: | FIRST MIDCATH CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Contact | C.j. Welle |
Correspondent | C.j. Welle BECTON DICKINSON INFUSION THERAPY SYSTEMS, 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 | 1997-06-16 |
Decision Date | 1997-09-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20886333209815 | K972254 | 000 |
20886333209808 | K972254 | 000 |
20886333209792 | K972254 | 000 |
20886333209785 | K972254 | 000 |