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)

Wedge XL Delivery Catheter

K-Number: K232542 · 2024-05-16

ApplicantMicroVention, Inc.
Decision Date2024-05-16
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wedge XL Delivery Catheter is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2024-05-16 under approval number K232542. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wedge XL Delivery Catheter?

Wedge XL Delivery Catheter is a medical device that received FDA 510(k) clearance on 2024-05-16. It is manufactured by MicroVention, Inc.. The 510(k) number is K232542.

When was Wedge XL Delivery Catheter approved by the FDA?

Wedge XL Delivery Catheter received FDA 510(k) clearance on 2024-05-16, under approval number K232542.

What company makes Wedge XL Delivery Catheter?

Wedge XL Delivery Catheter is manufactured by MicroVention, Inc..

What is the FDA product code for Wedge XL Delivery Catheter?

The FDA product code for Wedge XL Delivery Catheter is QJP.

Related Clinical Trials

NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT02761889 Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer COMPLETED NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT07575191 Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer NOT_YET_RECRUITING NCT07019623 U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women. RECRUITING

Other Devices by MicroVention, Inc.

K163154Traxcess 7 Mini XSoft Guidewire K161803Traxcess .007 Mini Guidewire K161367HydroCoil Embolic System (HES) K161452MicroPlex Coil System (MCS) - HyperSoft 3D K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System

View all 28 devices →

Related Devices (Code: QJP)

K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. K201682RIST Radial Access CatheterRist Neurovascular, Inc. K201518Route 92 Medical 088 Access SystemRoute 92 Medical K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. K200910BOSS Balloon Guide CatheterMarblehead Medical K200417RIST Radial Access CatheterRist Neurovascular, 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.

↑