MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL— 510(k) K964172

Clearance details

Applicant

Medtronic Vascular

Product code

Code GZB

Device class

Class 2

Regulation

21 CFR 882.5880

Advisory panel

Neurology

Date received

1996-10-18

Decision date

1997-07-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minneapolis, MN, US

• K233801 — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation2024-08-23
• K221376 — Nalu Neurostimulation System2022-06-10
• K203547 — Nalu Neurostimulation System2021-03-25
• K202274 — Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits2020-11-09
• K201618 — Nalu Neurostimulation SCS system2020-07-15

• K232570 — Steerant Super Stiff Guidewire2023-10-24
• K232190 — 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter2023-08-22
• K230156 — 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter2023-06-30
• K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more2022-04-13
• K192296 — Medtronic 6F Taiga Guiding Catheter2019-09-20

Death

4

Injury

1,879

Other

2

Total

1,885

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →