STERILEMED REPROCESSED IVUS IMAGING CATHETER

Reprocessed Intravascular Ultrasound Catheter

STERILMED, INC.

The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Sterilemed Reprocessed Ivus Imaging Catheter.

Pre-market Notification Details

Device IDK043453
510k NumberK043453
Device Name:STERILEMED REPROCESSED IVUS IMAGING CATHETER
ClassificationReprocessed Intravascular Ultrasound Catheter
Applicant STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove,  MN  55369
ContactBruce Lester
CorrespondentBruce Lester
STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove,  MN  55369
Product CodeOWQ  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-15
Decision Date2005-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888551044349 K043453 000
10888551044332 K043453 000
10888551044325 K043453 000
10888551044318 K043453 000
10888551004749 K043453 000
10888551004732 K043453 000
10888551004725 K043453 000
10888551004718 K043453 000
10888551004701 K043453 000

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