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FDA 510(k)

RX VIATRAC 14 PERIPHERAL DILATATION CATHETER

K-Number: K000101 · 2000-02-10

ApplicantGuidant Corp.
Decision Date2000-02-10
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RX VIATRAC 14 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 2000-02-10 under 510(k) number K000101. 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 RX VIATRAC 14 PERIPHERAL DILATATION CATHETER?

RX VIATRAC 14 PERIPHERAL DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2000-02-10. The listed applicant is Guidant Corp.. The 510(k) number is K000101.

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

RX VIATRAC 14 PERIPHERAL DILATATION CATHETER received FDA 510(k) clearance on 2000-02-10, under 510(k) number K000101.

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

The FDA product code for RX VIATRAC 14 PERIPHERAL DILATATION 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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