FDA 510(k)

PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18

K-Number: K013120 · 2002-01-24

Decision Date2002-01-24

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 is the device name listed in this FDA 510(k) record. The listed applicant is Medamicus, Inc.. It received FDA 510(k) clearance on 2002-01-24 under 510(k) number K013120. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18?

PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 is a medical device that received FDA 510(k) clearance on 2002-01-24. The listed applicant is Medamicus, Inc.. The 510(k) number is K013120.

When did PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 receive FDA 510(k) clearance?

PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 received FDA 510(k) clearance on 2002-01-24, under 510(k) number K013120.

Who is the listed applicant for PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18?

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

What is the FDA product code for PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18?

The FDA product code for PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 is GZB.

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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.