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FDA 510(k)

Zoom 6F Insert Catheters

K-Number: K233975 · 2024-04-02

ApplicantImperative Care, Inc.
Decision Date2024-04-02
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zoom 6F Insert Catheters 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 2024-04-02 under 510(k) number K233975. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zoom 6F Insert Catheters?

Zoom 6F Insert Catheters is a medical device that received FDA 510(k) clearance on 2024-04-02. The listed applicant is Imperative Care, Inc.. The 510(k) number is K233975.

When did Zoom 6F Insert Catheters receive FDA 510(k) clearance?

Zoom 6F Insert Catheters received FDA 510(k) clearance on 2024-04-02, under 510(k) number K233975.

Who is the listed applicant for Zoom 6F Insert Catheters?

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 6F Insert Catheters?

The FDA product code for Zoom 6F Insert Catheters is DQO.

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: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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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