FDA 510(k)

MEDTRONIC MODEL 9408 TELETRACE TRANSMIT

K-Number: K792246 · 1979-11-21

Decision Date1979-11-21

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC MODEL 9408 TELETRACE TRANSMIT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1979-11-21 under 510(k) number K792246. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC MODEL 9408 TELETRACE TRANSMIT?

MEDTRONIC MODEL 9408 TELETRACE TRANSMIT is a medical device that received FDA 510(k) clearance on 1979-11-21. The listed applicant is Medtronic Vascular. The 510(k) number is K792246.

When did MEDTRONIC MODEL 9408 TELETRACE TRANSMIT receive FDA 510(k) clearance?

MEDTRONIC MODEL 9408 TELETRACE TRANSMIT received FDA 510(k) clearance on 1979-11-21, under 510(k) number K792246.

Who is the listed applicant for MEDTRONIC MODEL 9408 TELETRACE TRANSMIT?

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 MODEL 9408 TELETRACE TRANSMIT?

The FDA product code for MEDTRONIC MODEL 9408 TELETRACE TRANSMIT is DXH. This falls under the Hematology category.

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: DXH)

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, 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.