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FDA 510(k)

Zoom System

K-Number: K242672 · 2025-01-14

ApplicantImperative Care, Inc.
Decision Date2025-01-14
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zoom System is a medical device manufactured by Imperative Care, Inc.. It received FDA 510(k) clearance on 2025-01-14 under approval number K242672. 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 System?

Zoom System is a medical device that received FDA 510(k) clearance on 2025-01-14. It is manufactured by Imperative Care, Inc.. The 510(k) number is K242672.

When was Zoom System approved by the FDA?

Zoom System received FDA 510(k) clearance on 2025-01-14, under approval number K242672.

What company makes Zoom System?

Zoom System is manufactured by Imperative Care, Inc..

What is the FDA product code for Zoom System?

The FDA product code for Zoom System is NRY.

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: NRY)

K161879Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc. K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

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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