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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 a medical device manufactured by Imperative Care, Inc.. It received FDA 510(k) clearance on 2024-04-02 under approval 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. It is manufactured by Imperative Care, Inc.. The 510(k) number is K233975.

When was Zoom 6F Insert Catheters approved by the FDA?

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

What company makes Zoom 6F Insert Catheters?

Zoom 6F Insert Catheters is manufactured by Imperative Care, Inc..

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

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION

Other Devices by Imperative Care, Inc.

K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length K1830430.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

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Related Devices (Code: DQO)

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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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