FDA 510(k) Premarket Notification K945103: TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)

Submission Details & Decision

Normalized public record details for 510(k) notification K945103.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K945103

Applicant / Sponsor

Medtronic Vascular

Device Name

TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)

Product Code

GZB

Decision Date

1995-01-11

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Neurology (NE)

Clearance Type

Traditional

Third Party Flag

Date Received

1994-10-18

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.