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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 the device name listed in this FDA 510(k) record. The listed applicant is Unity Medical, Inc.. It received FDA 510(k) clearance on 2025-10-24 under 510(k) 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. The listed applicant is Unity Medical, Inc.. The 510(k) number is K251372.

When did VersaD Delivery Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for VersaD Delivery Catheter?

The FDA 510(k) record lists Unity Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VersaD Delivery Catheter?

The FDA product code for VersaD Delivery Catheter is QJP.

Other records listing Unity Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242051VersaD Delivery Catheter

Related Devices (Code: QJP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

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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