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FDA 510(k)

VersaD Delivery Catheter

K-Number: K251372 · 2025-10-24

ApplicantUnity Medical, Inc.
Decision Date2025-10-24
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VersaD Delivery Catheter is a medical device manufactured by Unity Medical, Inc.. It received FDA 510(k) clearance on 2025-10-24 under approval number K251372. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VersaD Delivery Catheter?

VersaD Delivery Catheter is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Unity Medical, Inc.. The 510(k) number is K251372.

When was VersaD Delivery Catheter approved by the FDA?

VersaD Delivery Catheter received FDA 510(k) clearance on 2025-10-24, under approval number K251372.

What company makes VersaD Delivery Catheter?

VersaD Delivery Catheter is manufactured by Unity Medical, Inc..

What is the FDA product code for VersaD Delivery Catheter?

The FDA product code for VersaD Delivery Catheter is QJP.

Related Clinical Trials

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Other Devices by Unity Medical, Inc.

K242051VersaD Delivery Catheter

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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