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FDA 510(k)

Zoom System (Zoom 4S Catheter)

K-Number: K252046 · 2025-10-30

ApplicantImperative Care, Inc.
Decision Date2025-10-30
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zoom System (Zoom 4S Catheter) is a medical device manufactured by Imperative Care, Inc.. It received FDA 510(k) clearance on 2025-10-30 under approval number K252046. 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 4S Catheter)?

Zoom System (Zoom 4S Catheter) is a medical device that received FDA 510(k) clearance on 2025-10-30. It is manufactured by Imperative Care, Inc.. The 510(k) number is K252046.

When was Zoom System (Zoom 4S Catheter) approved by the FDA?

Zoom System (Zoom 4S Catheter) received FDA 510(k) clearance on 2025-10-30, under approval number K252046.

What company makes Zoom System (Zoom 4S Catheter)?

Zoom System (Zoom 4S Catheter) is manufactured by Imperative Care, Inc..

What is the FDA product code for Zoom System (Zoom 4S Catheter)?

The FDA product code for Zoom System (Zoom 4S Catheter) is NRY.

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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)

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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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