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FDA 510(k)

Armada™ 14 NC PTA Catheter

K-Number: K252512 · 2026-02-13

ApplicantABBOTT MEDICAL
Decision Date2026-02-13
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Armada™ 14 NC PTA Catheter is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K252512. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Armada™ 14 NC PTA Catheter?

Armada™ 14 NC PTA Catheter is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K252512.

When did Armada™ 14 NC PTA Catheter receive FDA 510(k) clearance?

Armada™ 14 NC PTA Catheter received FDA 510(k) clearance on 2026-02-13, under 510(k) number K252512.

Who is the listed applicant for Armada™ 14 NC PTA Catheter?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Armada™ 14 NC PTA Catheter?

The FDA product code for Armada™ 14 NC PTA Catheter is LIT.

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Related Devices (Code: LIT)

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.

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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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