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FDA 510(k)

AGILTRAC .035 PERIPHERAL DILATATION CATHETER

K-Number: K022738 · 2002-09-13

ApplicantGuidant Corp.
Decision Date2002-09-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AGILTRAC .035 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 2002-09-13 under 510(k) number K022738. 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 AGILTRAC .035 PERIPHERAL DILATATION CATHETER?

AGILTRAC .035 PERIPHERAL DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2002-09-13. The listed applicant is Guidant Corp.. The 510(k) number is K022738.

When did AGILTRAC .035 PERIPHERAL DILATATION CATHETER receive FDA 510(k) clearance?

AGILTRAC .035 PERIPHERAL DILATATION CATHETER received FDA 510(k) clearance on 2002-09-13, under 510(k) number K022738.

Who is the listed applicant for AGILTRAC .035 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 AGILTRAC .035 PERIPHERAL DILATATION CATHETER?

The FDA product code for AGILTRAC .035 PERIPHERAL DILATATION CATHETER is 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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