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FDA 510(k)

Highlander™ 014 PTA Balloon Dilatation Catheter

K-Number: K223177 · 2023-01-20

ApplicantC.R. Bard, Inc.
Decision Date2023-01-20
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Highlander™ 014 PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K223177. 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 Highlander™ 014 PTA Balloon Dilatation Catheter?

Highlander™ 014 PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K223177.

When did Highlander™ 014 PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

Highlander™ 014 PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2023-01-20, under 510(k) number K223177.

Who is the listed applicant for Highlander™ 014 PTA Balloon Dilatation Catheter?

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

What is the FDA product code for Highlander™ 014 PTA Balloon Dilatation Catheter?

The FDA product code for Highlander™ 014 PTA Balloon Dilatation Catheter is LIT.

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.

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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.

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