LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension

Catheter, Percutaneous

Seigla Medical, Inc.

The following data is part of a premarket notification filed by Seigla Medical, Inc. with the FDA for Liquid 061 Guide Catheter Extension, Liquid 071 Guide Catheter Extension.

Pre-market Notification Details

Device IDK220691
510k NumberK220691
Device Name:LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension
ClassificationCatheter, Percutaneous
Applicant Seigla Medical, Inc. 7688 5th Street SE Buffalo,  MN  55313
ContactChad J. Kugler
CorrespondentCraig R. Schlawin
Seigla Medical, Inc. 7688 5th Street SE Buffalo,  MN  55313
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-09
Decision Date2022-05-05

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