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FDA 510(k)

VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

K-Number: K012050 · 2001-09-06

ApplicantGuidant Corp.
Decision Date2001-09-06
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corp.. It received FDA 510(k) clearance on 2001-09-06 under 510(k) number K012050. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER?

VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2001-09-06. The listed applicant is Guidant Corp.. The 510(k) number is K012050.

When did VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER receive FDA 510(k) clearance?

VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER received FDA 510(k) clearance on 2001-09-06, under 510(k) number K012050.

Who is the listed applicant for VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER?

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

What is the FDA product code for VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER?

The FDA product code for VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER is DQY.

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Related Devices (Code: DQY)

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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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