Phenom 27 Catheter

Catheter, Percutaneous

Cathera, Inc.

The following data is part of a premarket notification filed by Cathera, Inc. with the FDA for Phenom 27 Catheter.

Pre-market Notification Details

Device IDK180959
510k NumberK180959
Device Name:Phenom 27 Catheter
ClassificationCatheter, Percutaneous
Applicant Cathera, Inc. 627 National Ave. Mountain View,  CA  94043
ContactVictor Ham
CorrespondentVictor Ham
Cathera, Inc. 627 National Ave. Mountain View,  CA  94043
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-12
Decision Date2018-06-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00763000270605 K180959 000
00763000270216 K180959 000

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