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FDA PMA

DEVICE, ANGIOPLASTY, LASER, CORONARY

PMA Number: P910001 · 2026-08-21

ApplicantSpectranetics Corp.
Decision Date2026-08-21
PMA NumberP910001
Product CodeLPC
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

DEVICE, ANGIOPLASTY, LASER, CORONARY is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics Corp.. It received FDA 510(k) clearance on 2026-08-21. The device is classified under product code LPC. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the DEVICE, ANGIOPLASTY, LASER, CORONARY?

DEVICE, ANGIOPLASTY, LASER, CORONARY is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Spectranetics Corp..

When did DEVICE, ANGIOPLASTY, LASER, CORONARY receive FDA 510(k) clearance?

The clearance date for DEVICE, ANGIOPLASTY, LASER, CORONARY can be found in the official FDA records.

Who is the listed applicant for DEVICE, ANGIOPLASTY, LASER, CORONARY?

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

What is the FDA product code for DEVICE, ANGIOPLASTY, LASER, CORONARY?

The FDA product code for DEVICE, ANGIOPLASTY, LASER, CORONARY is LPC.

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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