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FDA 510(k)

ATLAS PTA BALLOON DILATATION CATHETER

K-Number: K120971 · 2012-04-19

ApplicantBard Peripheral Vascular, Inc.
Decision Date2012-04-19
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATLAS PTA BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2012-04-19 under 510(k) number K120971. 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 ATLAS PTA BALLOON DILATATION CATHETER?

ATLAS PTA BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2012-04-19. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K120971.

When did ATLAS PTA BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

ATLAS PTA BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2012-04-19, under 510(k) number K120971.

Who is the listed applicant for ATLAS PTA BALLOON DILATATION CATHETER?

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

What is the FDA product code for ATLAS PTA BALLOON DILATATION CATHETER?

The FDA product code for ATLAS PTA BALLOON DILATATION CATHETER is LIT.

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Related Devices (Code: 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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