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FDA 510(k)

Zoom 4S Catheter

K-Number: K261176 · 2026-08-28

ApplicantImperative Care, Inc.
Decision Date2026-08-28
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zoom 4S Catheter 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 2026-08-28 under 510(k) number K261176. 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 Zoom 4S Catheter?

Zoom 4S Catheter is a medical device that received FDA 510(k) clearance on 2026-08-28. The listed applicant is Imperative Care, Inc.. The 510(k) number is K261176.

When did Zoom 4S Catheter receive FDA 510(k) clearance?

Zoom 4S Catheter received FDA 510(k) clearance on 2026-08-28, under 510(k) number K261176.

Who is the listed applicant for Zoom 4S Catheter?

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 Zoom 4S Catheter?

The FDA product code for Zoom 4S Catheter 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

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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.

K254071p17 XR MicrocatheterWallaby MedicalK260199SLIM 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 Neuro

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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