FDA 510(k)

MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT

K-Number: K932202 · 1994-05-04

Decision Date1994-05-04

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING 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 1994-05-04 under 510(k) number K932202. 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 MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT?

MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT is a medical device that received FDA 510(k) clearance on 1994-05-04. The listed applicant is Medtronic Vascular. The 510(k) number is K932202.

When did MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT receive FDA 510(k) clearance?

MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT received FDA 510(k) clearance on 1994-05-04, under 510(k) number K932202.

Who is the listed applicant for MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING 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 MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT?

The FDA product code for MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT 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.