ReCross

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 Recross.

Pre-market Notification Details

Device IDK210431
510k NumberK210431
Device Name:ReCross
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-12
Decision Date2021-07-15

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