REVASC THROMBECTOMY DEVICE

Catheter, Embolectomy

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Revasc Thrombectomy Device.

Pre-market Notification Details

Device IDK132281
510k NumberK132281
Device Name:REVASC THROMBECTOMY DEVICE
ClassificationCatheter, Embolectomy
Applicant Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactAmarilys Machado
CorrespondentAmarilys Machado
Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-23
Decision Date2013-08-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886704074779 K132281 000

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