Viatrac 14 Plus Peripheral Dilatation Catheter
K-Number: K221057 · 2022-05-05
ApplicantAbbott Vascular
Decision Date2022-05-05
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Viatrac 14 Plus Peripheral Dilatation Catheter is a medical device manufactured by Abbott Vascular. It received FDA 510(k) clearance on 2022-05-05 under approval number K221057. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Viatrac 14 Plus Peripheral Dilatation Catheter?
Viatrac 14 Plus Peripheral Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-05-05. It is manufactured by Abbott Vascular. The 510(k) number is K221057.
When was Viatrac 14 Plus Peripheral Dilatation Catheter approved by the FDA?
Viatrac 14 Plus Peripheral Dilatation Catheter received FDA 510(k) clearance on 2022-05-05, under approval number K221057.
What company makes Viatrac 14 Plus Peripheral Dilatation Catheter?
Viatrac 14 Plus Peripheral Dilatation Catheter is manufactured by Abbott Vascular.
What is the FDA product code for Viatrac 14 Plus Peripheral Dilatation Catheter?
The FDA product code for Viatrac 14 Plus Peripheral Dilatation Catheter is LIT.
Related Clinical Trials
NCT07512986
Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students
NOT_YET_RECRUITING
NCT05650411
Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs. Conventional DAPT for Unprotected Left Main Coronary Artery Disease (ULTIMATE-LM)
RECRUITING
NCT06455228
Long Peripheral Intravenous Catheter Insertion Site and Catheter-related Complications in Antimicrobial Therapy
COMPLETED
NCT00698607
Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing
COMPLETED
NCT01931579
Assessment of Probe Based Confocal Laser Endo-microscopy for In-vivo Diagnosis of Peripheral Lung Nodules and Masses.
COMPLETED
NCT07397390
an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions
ENROLLING_BY_INVITATION
Other Devices by Abbott Vascular
K161985Steerable Guide Catheter
K172394Steerable Guide Catheter
K172073Hi-Torque Command 18 Guide Wire
K180040NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter; TREK RX Coronary Dilatation Catheter; TREK OTW Coronary Dilatation Catheter; MINI TREK RX Coronary Dilatation Catheter; MINI TREK OTW Coronary Dilatation Catheter; MINI TREK II OTW Coronary Dilatation Catheter
K173795HI-TORQUE TurnTrac Guide Wire Family
K193126HI-TORQUE InfilTrac Guide Wire Family
Related Devices (Code: LIT)
K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.
K162316Pirouette 014Arravasc, Ltd.
K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018Boston Scientific Corporation
K161427Pirouette 035Arravasc Limited
K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.
K160004Crosstella OTWKANEKA Corporation
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.