Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform

K-Number: K203764 · 2021-03-03

ApplicantImperative Care, Inc.
Decision Date2021-03-03
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform is the device name listed in this FDA 510(k) record. The listed applicant is Imperative Care, Inc.. It received FDA 510(k) clearance on 2021-03-03 under 510(k) number K203764. 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 Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform?

TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform is a medical device that received FDA 510(k) clearance on 2021-03-03. The listed applicant is Imperative Care, Inc.. The 510(k) number is K203764.

When did TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform receive FDA 510(k) clearance?

TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform received FDA 510(k) clearance on 2021-03-03, under 510(k) number K203764.

Who is the listed applicant for TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform?

The FDA 510(k) record lists Imperative Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform?

The FDA product code for TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform is QJP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06062329SYMPHONY-PE Study for Treatment of Pulmonary EmbolismCOMPLETEDNCT07350499Aspiration Thrombectomy Using the Symphony or Prodigy SystemRECRUITINGNCT07491952Continuous Dual Aspiration Technique With Zoom System for StrokeRECRUITING

Other records listing Imperative Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252046Zoom System (Zoom 4S Catheter)K252057Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy SystemK244061X-Wire GuidewireK243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingK250775Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy SystemK242672Zoom System

View all 17 devices →

Related Devices (Code: QJP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

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.

↑