TrapIt

Catheter, Percutaneous

IMDS Operations B.V.

The following data is part of a premarket notification filed by Imds Operations B.v. with the FDA for Trapit.

Pre-market Notification Details

Device IDK191229
510k NumberK191229
Device Name:TrapIt
ClassificationCatheter, Percutaneous
Applicant IMDS Operations B.V. Ceintuurbaan Noord 150 Roden,  NL 9301 Nz
ContactEdwin Schulting
CorrespondentEdwin Schulting
IMDS Operations B.V. Ceintuurbaan Noord 150 Roden,  NL 9301 Nz
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-08
Decision Date2020-01-21

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