BOLTON PTA CATHETER

Catheter, Angioplasty, Peripheral, Transluminal

Bolton Medical, Inc.

The following data is part of a premarket notification filed by Bolton Medical, Inc. with the FDA for Bolton Pta Catheter.

Pre-market Notification Details

Device IDK021996
510k NumberK021996
Device Name:BOLTON PTA CATHETER
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant Bolton Medical, Inc. 16-00 POLLITT DR. Fair Lawn,  NJ  07410
ContactVivian Kelly
CorrespondentVivian Kelly
Bolton Medical, Inc. 16-00 POLLITT DR. Fair Lawn,  NJ  07410
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-18
Decision Date2002-08-23
Summary:summary

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