TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform

Catheter, Percutaneous, Neurovasculature

Imperative Care Inc.

The following data is part of a premarket notification filed by Imperative Care Inc. with the FDA for Tracstar Ldp Large Distal Platform; Zoom 88 Large Distal Platform.

Pre-market Notification Details

Device IDK212224
510k NumberK212224
Device Name:TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
ClassificationCatheter, Percutaneous, Neurovasculature
Applicant Imperative Care Inc. 1359 Dell Avenue Campbell,  CA  95008
ContactKristin Ellis
CorrespondentKristin Ellis
Imperative Care Inc. 1359 Dell Avenue Campbell,  CA  95008
Product CodeQJP  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-16
Decision Date2021-09-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812212030368 K212224 000
00812212030351 K212224 000
00812212030344 K212224 000
00812212030337 K212224 000

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