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FDA 510(k)

AVE GL-1 GUIDING CATHETER

K-Number: K984482 · 1999-07-30

ApplicantArterial Vascular Engineering Massachusetts, Inc.
Decision Date1999-07-30
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVE GL-1 GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Arterial Vascular Engineering Massachusetts, Inc.. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K984482. 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 AVE GL-1 GUIDING CATHETER?

AVE GL-1 GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Arterial Vascular Engineering Massachusetts, Inc.. The 510(k) number is K984482.

When did AVE GL-1 GUIDING CATHETER receive FDA 510(k) clearance?

AVE GL-1 GUIDING CATHETER received FDA 510(k) clearance on 1999-07-30, under 510(k) number K984482.

Who is the listed applicant for AVE GL-1 GUIDING CATHETER?

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

What is the FDA product code for AVE GL-1 GUIDING CATHETER?

The FDA product code for AVE GL-1 GUIDING CATHETER is DQY.

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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