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FDA 510(k)

GORE TRI-LOBE BALLOON CATHETER

K-Number: K033670 · 2004-05-05

ApplicantW. L. Gore & Associates, Inc.
Decision Date2004-05-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE TRI-LOBE BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2004-05-05 under 510(k) number K033670. 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 GORE TRI-LOBE BALLOON CATHETER?

GORE TRI-LOBE BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2004-05-05. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K033670.

When did GORE TRI-LOBE BALLOON CATHETER receive FDA 510(k) clearance?

GORE TRI-LOBE BALLOON CATHETER received FDA 510(k) clearance on 2004-05-05, under 510(k) number K033670.

Who is the listed applicant for GORE TRI-LOBE BALLOON CATHETER?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE TRI-LOBE BALLOON CATHETER?

The FDA product code for GORE TRI-LOBE BALLOON CATHETER is DQY.

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Other records listing W. L. Gore & Associates, Inc. as applicant

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.

K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

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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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