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 IDK210996
510k NumberK210996
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
ContactKristin Ellis
CorrespondentKristin Ellis
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 Received2021-04-02
Decision Date2021-04-23

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.