ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

Catheter, Thrombus Retriever

Imperative Care Inc.

The following data is part of a premarket notification filed by Imperative Care Inc. with the FDA for Zoom (71, 55, 45, 35) Reperfusion Catheters; Zoom Aspiration Tubing.

Pre-market Notification Details

Device IDK202182
510k NumberK202182
Device Name:ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
ClassificationCatheter, Thrombus Retriever
Applicant Imperative Care Inc. 1359 Dell Avenue Campbell,  CA  95008
ContactJake Wolenberg
CorrespondentJake Wolenberg
Imperative Care Inc. 1359 Dell Avenue Campbell,  CA  95008
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-04
Decision Date2020-09-02

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