AXS Catalyst 7 Distal Access Catheter (068 X 115cm, 068 X 125cm, 068 X 132cm)

Catheter, Thrombus Retriever

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Axs Catalyst 7 Distal Access Catheter (068 X 115cm, 068 X 125cm, 068 X 132cm).

Pre-market Notification Details

Device IDK183464
510k NumberK183464
Device Name:AXS Catalyst 7 Distal Access Catheter (068 X 115cm, 068 X 125cm, 068 X 132cm)
ClassificationCatheter, Thrombus Retriever
Applicant Stryker 47900 Bayside Parkway Fremont,  CA  94538
ContactGermaine Fu
CorrespondentGermaine Fu
Stryker 47900 Bayside Parkway Fremont,  CA  94538
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-14
Decision Date2019-03-13

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