VaPro 2 Intermittent Catheter

Catheter, Urethral

Hollister Incorporated

The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Vapro 2 Intermittent Catheter.

Pre-market Notification Details

Device IDK180824
510k NumberK180824
Device Name:VaPro 2 Intermittent Catheter
ClassificationCatheter, Urethral
Applicant Hollister Incorporated 2000 Hollister Drive Libertyville,  IL  60048
ContactMichelle Schiltz-taing
CorrespondentMichelle Schiltz-taing
Hollister Incorporated 2000 Hollister Drive Libertyville,  IL  60048
Product CodeGBM  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-30
Decision Date2018-06-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00610075067985 K180824 000
00610075067978 K180824 000
00610075067893 K180824 000
00610075067787 K180824 000

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