FDA 510(k)

GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582

K-Number: K073200 · 2008-02-01

Decision Date2008-02-01

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 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 2008-02-01 under 510(k) number K073200. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582?

GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 is a medical device that received FDA 510(k) clearance on 2008-02-01. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K073200.

When did GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 receive FDA 510(k) clearance?

GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 received FDA 510(k) clearance on 2008-02-01, under 510(k) number K073200.

Who is the listed applicant for GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582?

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 GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582?

The FDA product code for GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 is DQO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.