ANGIOCATH & INSYTE AUTOGUARD CATHETERS

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

BECTON DICKINSON VASCULAR ACCESS, INC.

The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for Angiocath & Insyte Autoguard Catheters.

Pre-market Notification Details

Device IDK952861
510k NumberK952861
Device Name:ANGIOCATH & INSYTE AUTOGUARD CATHETERS
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy,  UT  84070
ContactC. J. Welle
CorrespondentC. J. Welle
BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy,  UT  84070
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-22
Decision Date1995-07-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40612479249903 K952861 000
50382903814126 K952861 000
50382903814232 K952861 000
50382903814331 K952861 000
50382903814348 K952861 000
50382903814379 K952861 000
50382903814447 K952861 000
50382903814478 K952861 000
50382903814546 K952861 000
50382903814577 K952861 000
50382903814676 K952861 000
50382903814119 K952861 000
40612479250237 K952861 000
40612479249934 K952861 000
40612479249965 K952861 000
40612479249996 K952861 000
40612479250022 K952861 000
40612479250053 K952861 000
40612479250084 K952861 000
40612479250114 K952861 000
40612479250145 K952861 000
40612479250176 K952861 000
40612479250206 K952861 000
50382903815116 K952861 000
50382903815123 K952861 000
50382903817042 K952861 000
50382903817059 K952861 000
50382903817066 K952861 000
50382903817073 K952861 000
50382903817080 K952861 000
50382903817097 K952861 000
50382903817202 K952861 000
30382903818120 K952861 000
30382903818236 K952861 000
30382903818342 K952861 000
50382903817035 K952861 000
50382903817028 K952861 000
50382903815239 K952861 000
50382903815338 K952861 000
50382903815345 K952861 000
50382903815376 K952861 000
50382903815444 K952861 000
50382903815475 K952861 000
50382903815543 K952861 000
50382903815574 K952861 000
50382903817004 K952861 000
50382903817011 K952861 000
30382903818441 K952861 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.