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

FDA 510(k)

basixTOUCH40 Inflation Syringe

K-Number: K153672 · 2016-01-20

ApplicantMerit Medical Systems, Inc.
Decision Date2016-01-20
Product CodeMAV
Advisory CommitteeCV
DecisionUnknown

Device Summary

basixTOUCH40 Inflation Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K153672. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the basixTOUCH40 Inflation Syringe?

basixTOUCH40 Inflation Syringe is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K153672.

When did basixTOUCH40 Inflation Syringe receive FDA 510(k) clearance?

basixTOUCH40 Inflation Syringe received FDA 510(k) clearance on 2016-01-20, under 510(k) number K153672.

Who is the listed applicant for basixTOUCH40 Inflation Syringe?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for basixTOUCH40 Inflation Syringe?

The FDA product code for basixTOUCH40 Inflation Syringe is MAV.

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.

NCT03311451C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.ACTIVE_NOT_RECRUITINGNCT04540302The Merit WRAPSODY AV Access Efficacy Study (WAVE)COMPLETEDNCT05050799US Post-Market Surveillance Study of the Surfacer SystemRECRUITINGNCT06153667Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)RECRUITINGNCT06422871PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on HemodialysisRECRUITINGNCT06587282PREEMIE: Study for Treatment of PDA in Premature InfantsACTIVE_NOT_RECRUITING

Other records listing Merit Medical Systems, Inc. as applicant

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetK262086PreludeSYNC™ Radial Compression DevicePMA P240023System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatmentK254073StatSeal DiscK251802STAR RF Ablation SystemK252892SCOUT MD Surgical Guidance System

View all 68 devices →

Related Devices (Code: MAV)

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.

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)Medtronic VascularK162272Fluent inflation deviceVascular Solutions, Inc.K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMedtronic, 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.

↑