Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Telescope Guide Extension Catheter

K-Number: K183353 · 2019-03-22

ApplicantMedtronic, Inc.
Decision Date2019-03-22
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Telescope Guide Extension Catheter is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2019-03-22 under approval number K183353. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Telescope Guide Extension Catheter?

Telescope Guide Extension Catheter is a medical device that received FDA 510(k) clearance on 2019-03-22. It is manufactured by Medtronic, Inc.. The 510(k) number is K183353.

When was Telescope Guide Extension Catheter approved by the FDA?

Telescope Guide Extension Catheter received FDA 510(k) clearance on 2019-03-22, under approval number K183353.

What company makes Telescope Guide Extension Catheter?

Telescope Guide Extension Catheter is manufactured by Medtronic, Inc..

What is the FDA product code for Telescope Guide Extension Catheter?

The FDA product code for Telescope Guide Extension Catheter is DQY.

Related Clinical Trials

NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING NCT07576790 Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT) NOT_YET_RECRUITING

Other Devices by Medtronic, Inc.

K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface K162892Achieve Advance Mapping Catheter K162054Medtronic Temporary External Pacemaker 53401 K162550Medtronic Model 5392 External Pulse Generator (EPG) K162016Affinity NT Oxygenator with Cortiva BioActive Surface K160983Kyphon HV-R Bone Cement

View all 137 devices →

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire 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.

↑