CLEARWAY OTW MODEL 85912

Catheter, Percutaneous

ATRIUM MEDICAL CORP.

The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Clearway Otw Model 85912.

Pre-market Notification Details

Device IDK093431
510k NumberK093431
Device Name:CLEARWAY OTW MODEL 85912
ClassificationCatheter, Percutaneous
Applicant ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
ContactRaymond Kelly
CorrespondentRaymond Kelly
ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson,  NH  03051
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-04
Decision Date2010-04-20

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