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FDA 510(k)

X-Wire Guidewire

K-Number: K244061 · 2025-08-26

ApplicantImperative Care, Inc.
Decision Date2025-08-26
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

X-Wire Guidewire is a medical device manufactured by Imperative Care, Inc.. It received FDA 510(k) clearance on 2025-08-26 under approval number K244061. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-Wire Guidewire?

X-Wire Guidewire is a medical device that received FDA 510(k) clearance on 2025-08-26. It is manufactured by Imperative Care, Inc.. The 510(k) number is K244061.

When was X-Wire Guidewire approved by the FDA?

X-Wire Guidewire received FDA 510(k) clearance on 2025-08-26, under approval number K244061.

What company makes X-Wire Guidewire?

X-Wire Guidewire is manufactured by Imperative Care, Inc..

What is the FDA product code for X-Wire Guidewire?

The FDA product code for X-Wire Guidewire is MOF.

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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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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