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FDA PMA

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

PMA Number: P160049 · 2026-03-19

ApplicantThe Spectranetics Corp.
Decision Date2026-03-19
PMA NumberP160049
Product CodeONU
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Drug-Eluting Peripheral Transluminal Angioplasty Catheter is the device name listed in this FDA 510(k) record. The listed applicant is The Spectranetics Corp.. It received FDA 510(k) clearance on 2026-03-19. The device is classified under product code ONU. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Drug-Eluting Peripheral Transluminal Angioplasty Catheter?

Drug-Eluting Peripheral Transluminal Angioplasty Catheter is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is The Spectranetics Corp..

When did Drug-Eluting Peripheral Transluminal Angioplasty Catheter receive FDA 510(k) clearance?

The clearance date for Drug-Eluting Peripheral Transluminal Angioplasty Catheter can be found in the official FDA records.

Who is the listed applicant for Drug-Eluting Peripheral Transluminal Angioplasty Catheter?

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

What is the FDA product code for Drug-Eluting Peripheral Transluminal Angioplasty Catheter?

The FDA product code for Drug-Eluting Peripheral Transluminal Angioplasty Catheter is ONU.

Related Clinical Trials

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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