Tamarin Blue PTCA RX Dilatation Catheter

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Natec Medical Ltd.

The following data is part of a premarket notification filed by Natec Medical Ltd. with the FDA for Tamarin Blue Ptca Rx Dilatation Catheter.

Pre-market Notification Details

Device IDK210012
510k NumberK210012
Device Name:Tamarin Blue PTCA RX Dilatation Catheter
ClassificationCatheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant Natec Medical Ltd. Maeva Centra Building, Silicon Avenue Ebene Business Park Reduit,  MU 72201
ContactRoy Devassy Pallippatt
CorrespondentCandace Cederman
CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis,  MD  21401
Product CodeLOX  
CFR Regulation Number870.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-04
Decision Date2021-07-09

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