BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter

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

Becton, Dickinson And Company

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Insyte Autoguard Shielded Iv Catheter, Bd Insyte Autoguard Bc Shielded Iv Catheter, Bd Insyte Autoguard Bc Pro Shielded Iv Catheter.

Pre-market Notification Details

Device IDK201075
510k NumberK201075
Device Name:BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant Becton, Dickinson And Company 9450 South State Street Sandy,  UT  84070
ContactKimberly Geisler
CorrespondentKimberly Geisler
Becton, Dickinson And Company 9450 South State Street Sandy,  UT  84070
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-22
Decision Date2020-12-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50382903817004 K201075 000
50382903825344 K201075 000
30382903925231 K201075 000
50382903925242 K201075 000
50382903925334 K201075 000
50382903925341 K201075 000
50382903925440 K201075 000
50382903814119 K201075 000
50382903815444 K201075 000
50382903815574 K201075 000
30382903818236 K201075 000
50382903815123 K201075 000
50382903815345 K201075 000
50382903815543 K201075 000
50382903825238 K201075 000
50382903826440 K201075 000
50382903826549 K201075 000
50382903825375 K201075 000
50382903825337 K201075 000
50382903817011 K201075 000
50382903817028 K201075 000
50382903817035 K201075 000
50382903817042 K201075 000
50382903817059 K201075 000
50382903817066 K201075 000
50382903817073 K201075 000
50382903817080 K201075 000
50382903817097 K201075 000
30382903925545 K201075 000
50382903826235 K201075 000
50382903826334 K201075 000
50382903826341 K201075 000
50382903826372 K201075 000
50382903818117 K201075 000
30382903818342 K201075 000
50382903826570 K201075 000
50382903815239 K201075 000
50382903814546 K201075 000
50382903825443 K201075 000
50382903825474 K201075 000
50382903819114 K201075 000
50382903925471 K201075 000
30382903925125 K201075 000
50382903926249 K201075 000
50382903926577 K201075 000
30382903925378 K201075 000
50382903925570 K201075 000
50382903926126 K201075 000
50382903926232 K201075 000
50382903926331 K201075 000
30382903926344 K201075 000
50382903926379 K201075 000
50382903926447 K201075 000
30382903926474 K201075 000
30382903818441 K201075 000
50382903815376 K201075 000
50382903815116 K201075 000
50382903815338 K201075 000
50382903814126 K201075 000
50382903814232 K201075 000
50382903814331 K201075 000
50382903814348 K201075 000
50382903814478 K201075 000
50382903815475 K201075 000
30382903818120 K201075 000
50382903825542 K201075 000
50382903814447 K201075 000
50382903825122 K201075 000
50382903825573 K201075 000
50382903814379 K201075 000
50382903814577 K201075 000
50382903814676 K201075 000
30382903926542 K201075 000

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