FDA 510(k)

TEMPORARY SCREENING LEAD/CATHETER KIT

K-Number: K934938 · 1994-06-14

Decision Date1994-06-14

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TEMPORARY SCREENING LEAD/CATHETER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1994-06-14 under 510(k) number K934938. 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 TEMPORARY SCREENING LEAD/CATHETER KIT?

TEMPORARY SCREENING LEAD/CATHETER KIT is a medical device that received FDA 510(k) clearance on 1994-06-14. The listed applicant is Medtronic Vascular. The 510(k) number is K934938.

When did TEMPORARY SCREENING LEAD/CATHETER KIT receive FDA 510(k) clearance?

TEMPORARY SCREENING LEAD/CATHETER KIT received FDA 510(k) clearance on 1994-06-14, under 510(k) number K934938.

Who is the listed applicant for TEMPORARY SCREENING LEAD/CATHETER KIT?

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

What is the FDA product code for TEMPORARY SCREENING LEAD/CATHETER KIT?

The FDA product code for TEMPORARY SCREENING LEAD/CATHETER KIT is GZB.

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Related Devices (Code: 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.