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)

Ultraverse 014 and 018 PTA Balloon Dilatation Catheters

K-Number: K192318 · 2019-10-03

ApplicantBard Peripheral Vascular, Inc.
Decision Date2019-10-03
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ultraverse 014 and 018 PTA Balloon Dilatation Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K192318. 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 Ultraverse 014 and 018 PTA Balloon Dilatation Catheters?

Ultraverse 014 and 018 PTA Balloon Dilatation Catheters is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K192318.

When did Ultraverse 014 and 018 PTA Balloon Dilatation Catheters receive FDA 510(k) clearance?

Ultraverse 014 and 018 PTA Balloon Dilatation Catheters received FDA 510(k) clearance on 2019-10-03, under 510(k) number K192318.

Who is the listed applicant for Ultraverse 014 and 018 PTA Balloon Dilatation Catheters?

The FDA 510(k) record lists Bard Peripheral Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultraverse 014 and 018 PTA Balloon Dilatation Catheters?

The FDA product code for Ultraverse 014 and 018 PTA Balloon Dilatation Catheters is LIT.

Other records listing Bard Peripheral Vascular, 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.

K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemPMA P130029System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatmentPMA P180037Stent, iliac veinPMA P070014STENT, SUPERFICIAL FEMORAL ARTERYK260012UltraScore™ Focused Force PTA BalloonK252681EnCor EnCompass™ Breast Biopsy and Tissue Removal System

View all 26 devices →

Related Devices (Code: LIT)

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.

K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.

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.

↑