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FDA 510(k)

GOPHER GOLD CATHETER, MODEL 5620

K-Number: K091345 · 2009-06-12

ApplicantVascular Solutions, Inc.
Decision Date2009-06-12
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GOPHER GOLD CATHETER, MODEL 5620 is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2009-06-12 under 510(k) number K091345. 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 GOPHER GOLD CATHETER, MODEL 5620?

GOPHER GOLD CATHETER, MODEL 5620 is a medical device that received FDA 510(k) clearance on 2009-06-12. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K091345.

When did GOPHER GOLD CATHETER, MODEL 5620 receive FDA 510(k) clearance?

GOPHER GOLD CATHETER, MODEL 5620 received FDA 510(k) clearance on 2009-06-12, under 510(k) number K091345.

Who is the listed applicant for GOPHER GOLD CATHETER, MODEL 5620?

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

What is the FDA product code for GOPHER GOLD CATHETER, MODEL 5620?

The FDA product code for GOPHER GOLD CATHETER, MODEL 5620 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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