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FDA 510(k)

PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

K-Number: K052757 · 2005-10-28

ApplicantBiotronik AG
Decision Date2005-10-28
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik AG. It received FDA 510(k) clearance on 2005-10-28 under 510(k) number K052757. 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 PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER?

PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER is a medical device that received FDA 510(k) clearance on 2005-10-28. The listed applicant is Biotronik AG. The 510(k) number is K052757.

When did PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER receive FDA 510(k) clearance?

PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER received FDA 510(k) clearance on 2005-10-28, under 510(k) number K052757.

Who is the listed applicant for PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER?

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

What is the FDA product code for PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER?

The FDA product code for PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (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

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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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