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)

TriClip Steerable Guide Catheter

K-Number: K241538 · 2024-08-26

ApplicantABBOTT MEDICAL
Decision Date2024-08-26
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TriClip Steerable Guide Catheter is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2024-08-26 under approval number K241538. 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 TriClip Steerable Guide Catheter?

TriClip Steerable Guide Catheter is a medical device that received FDA 510(k) clearance on 2024-08-26. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K241538.

When was TriClip Steerable Guide Catheter approved by the FDA?

TriClip Steerable Guide Catheter received FDA 510(k) clearance on 2024-08-26, under approval number K241538.

What company makes TriClip Steerable Guide Catheter?

TriClip Steerable Guide Catheter is manufactured by ABBOTT MEDICAL.

What is the FDA product code for TriClip Steerable Guide Catheter?

The FDA product code for TriClip Steerable Guide 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 ABBOTT MEDICAL

K192267ILUMIEN System with AptiVue Software version D.3 K192019Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 K192037Advisor VL Circular Mapping Catheter, Sensor Enabled K190581Amplatzer Trevisio Intravascular Delivery System K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled K201610IonicRF Generator

View all 89 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.

↑