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FDA 510(k)

Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing

K-Number: K243047 · 2025-05-28

ApplicantImperative Care, Inc.
Decision Date2025-05-28
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing 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 2025-05-28 under 510(k) number K243047. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing?

Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing is a medical device that received FDA 510(k) clearance on 2025-05-28. The listed applicant is Imperative Care, Inc.. The 510(k) number is K243047.

When did Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing receive FDA 510(k) clearance?

Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing received FDA 510(k) clearance on 2025-05-28, under 510(k) number K243047.

Who is the listed applicant for Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing?

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 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing?

The FDA product code for Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing is NRY.

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.

NCT07491952Continuous Dual Aspiration Technique With Zoom System for StrokeRECRUITINGNCT06062329SYMPHONY-PE Study for Treatment of Pulmonary EmbolismCOMPLETEDNCT07350499Aspiration Thrombectomy Using the Symphony or Prodigy SystemRECRUITING

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 GuidewireK250775Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy SystemK242672Zoom SystemK240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support

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Related Devices (Code: NRY)

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.

K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou 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.

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