FDA 510(k)

EPIDURAL LEAD - MODEL 3481

K-Number: K780001 · 1978-01-17

Decision Date1978-01-17

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EPIDURAL LEAD - MODEL 3481 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1978-01-17 under 510(k) number K780001. 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 EPIDURAL LEAD - MODEL 3481?

EPIDURAL LEAD - MODEL 3481 is a medical device that received FDA 510(k) clearance on 1978-01-17. The listed applicant is Medtronic Vascular. The 510(k) number is K780001.

When did EPIDURAL LEAD - MODEL 3481 receive FDA 510(k) clearance?

EPIDURAL LEAD - MODEL 3481 received FDA 510(k) clearance on 1978-01-17, under 510(k) number K780001.

Who is the listed applicant for EPIDURAL LEAD - MODEL 3481?

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 EPIDURAL LEAD - MODEL 3481?

The FDA product code for EPIDURAL LEAD - MODEL 3481 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.