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FDA 510(k)

ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing

K-Number: K211476 · 2021-06-08

ApplicantImperative Care, Inc.
Decision Date2021-06-08
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOOM 71 Reperfusion Catheter; ZOOM 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 2021-06-08 under 510(k) number K211476. 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 71 Reperfusion Catheter; ZOOM Aspiration Tubing?

ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing is a medical device that received FDA 510(k) clearance on 2021-06-08. The listed applicant is Imperative Care, Inc.. The 510(k) number is K211476.

When did ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing receive FDA 510(k) clearance?

ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing received FDA 510(k) clearance on 2021-06-08, under 510(k) number K211476.

Who is the listed applicant for ZOOM 71 Reperfusion Catheter; ZOOM 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 71 Reperfusion Catheter; ZOOM Aspiration Tubing?

The FDA product code for ZOOM 71 Reperfusion Catheter; ZOOM 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

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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: 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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