FDA 510(k)

GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951

K-Number: K081846 · 2009-01-28

Decision Date2009-01-28

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 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 2009-01-28 under 510(k) number K081846. 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 GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951?

GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 is a medical device that received FDA 510(k) clearance on 2009-01-28. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K081846.

When did GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 receive FDA 510(k) clearance?

GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 received FDA 510(k) clearance on 2009-01-28, under 510(k) number K081846.

Who is the listed applicant for GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951?

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 GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951?

The FDA product code for GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 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.