Aqueduct 100 Plus Cervical Dilation Balloon Catheter

Catheter, Balloon, Dilation Of Cervical Canal

GTIMD LLC

The following data is part of a premarket notification filed by Gtimd Llc with the FDA for Aqueduct 100 Plus Cervical Dilation Balloon Catheter.

Pre-market Notification Details

Device IDK202427
510k NumberK202427
Device Name:Aqueduct 100 Plus Cervical Dilation Balloon Catheter
ClassificationCatheter, Balloon, Dilation Of Cervical Canal
Applicant GTIMD LLC 6 Columbia Drive Amherst,  NH  03031
ContactEran Levit
CorrespondentEran Levit
GTIMD LLC 6 Columbia Drive Amherst,  NH  03031
Product CodePON  
CFR Regulation Number884.4260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-25
Decision Date2020-11-06

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.