Revolution Peripheral Atherectomy System

Catheter, Peripheral, Atherectomy

Rex Medical, L.P.

The following data is part of a premarket notification filed by Rex Medical, L.p. with the FDA for Revolution Peripheral Atherectomy System.

Pre-market Notification Details

Device IDK212351
510k NumberK212351
Device Name:Revolution Peripheral Atherectomy System
ClassificationCatheter, Peripheral, Atherectomy
Applicant Rex Medical, L.P. 555 East North Lane, Suite 5035 Conshohocken,  PA  19428
ContactColin Valentis
CorrespondentColin Valentis
Rex Medical, L.P. 555 East North Lane, Suite 5035 Conshohocken,  PA  19428
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-29
Decision Date2021-12-15

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