FDA 510(k)

MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL

K-Number: K844115 · 1985-02-06

Decision Date1985-02-06

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1985-02-06 under 510(k) number K844115. 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 MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL?

MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL is a medical device that received FDA 510(k) clearance on 1985-02-06. The listed applicant is Medtronic Vascular. The 510(k) number is K844115.

When did MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL receive FDA 510(k) clearance?

MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL received FDA 510(k) clearance on 1985-02-06, under 510(k) number K844115.

Who is the listed applicant for MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL?

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 MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL?

The FDA product code for MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL is GZB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medtronic Vascular as applicant

K232570Steerant™ Super Stiff Guidewire K2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter K2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)K192296Medtronic 6F Taiga Guiding Catheter K173515Admiral Xtreme

View all 474 devices →

Related Devices (Code: GZB)

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation K221376Nalu Neurostimulation SystemBoston Scientific Neuromodulation K203547Nalu Neurostimulation SystemBoston Scientific Neuromodulation K202274Nalu 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 kitsBoston Scientific Neuromodulation K201618Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.