← Back to catalogue

Medtronic (3991a +3 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K964172

by Medtronic Vascular

Identifiers

510(k) Number
K964172 FDA 510(k)
FDA Product Code
GZB FDA 510(k)
Models / Variants
3991a FDA 510(k)
3992a FDA 510(k)
3993a FDA 510(k)
3994a Leads Or Transverse Tripolar Leads Or Ttl FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5880 FDA 510(k)
Regulation Number
882.5880 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Medtronic (3991a +3 more) by Medtronic Vascular — Class II — FDA_510K — listed in FDA 510(k) — 4 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K964172 24 fields · synced Jun 18, 2026