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FDA 510(k)

AMPHIRION PLUS PTA CATHETER

K-Number: K121265 · 2012-05-22

ApplicantMedtronic, Inc.
Decision Date2012-05-22
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMPHIRION PLUS PTA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2012-05-22 under 510(k) number K121265. 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 AMPHIRION PLUS PTA CATHETER?

AMPHIRION PLUS PTA CATHETER is a medical device that received FDA 510(k) clearance on 2012-05-22. The listed applicant is Medtronic, Inc.. The 510(k) number is K121265.

When did AMPHIRION PLUS PTA CATHETER receive FDA 510(k) clearance?

AMPHIRION PLUS PTA CATHETER received FDA 510(k) clearance on 2012-05-22, under 510(k) number K121265.

Who is the listed applicant for AMPHIRION PLUS PTA CATHETER?

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

What is the FDA product code for AMPHIRION PLUS PTA CATHETER?

The FDA product code for AMPHIRION PLUS PTA CATHETER is LIT.

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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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