Paladin Carotid Post-Dilation Balloon System With Integrated Embolic Protection

Catheter, Angioplasty, Peripheral, Transluminal

Contego Medical Inc.

The following data is part of a premarket notification filed by Contego Medical Inc. with the FDA for Paladin Carotid Post-dilation Balloon System With Integrated Embolic Protection.

Pre-market Notification Details

Device IDK221339
510k NumberK221339
Device Name:Paladin Carotid Post-Dilation Balloon System With Integrated Embolic Protection
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant Contego Medical Inc. 3801 Lake Boone Trail, Suite 100 Raleigh,  NC  27607
ContactJim Clossick
CorrespondentJim Clossick
Contego Medical Inc. 3801 Lake Boone Trail, Suite 100 Raleigh,  NC  27607
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-09
Decision Date2022-06-09

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