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FDA 510(k)

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform

K-Number: K212224 · 2021-09-20

ApplicantImperative Care, Inc.
Decision Date2021-09-20
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform is a medical device manufactured by Imperative Care, Inc.. It received FDA 510(k) clearance on 2021-09-20 under approval number K212224. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform?

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform is a medical device that received FDA 510(k) clearance on 2021-09-20. It is manufactured by Imperative Care, Inc.. The 510(k) number is K212224.

When was TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform approved by the FDA?

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform received FDA 510(k) clearance on 2021-09-20, under approval number K212224.

What company makes TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform?

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform is manufactured by Imperative Care, Inc..

What is the FDA product code for TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform?

The FDA product code for TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform is QJP.

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Other Devices by Imperative Care, Inc.

K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length K1830430.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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