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FDA 510(k)

Advance 14LP Low Profile PTA Balloon Dilatation Catheter

K-Number: K170193 · 2017-02-13

ApplicantCook Incorporated
Decision Date2017-02-13
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Advance 14LP Low Profile PTA Balloon Dilatation Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-02-13 under approval number K170193. 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 Advance 14LP Low Profile PTA Balloon Dilatation Catheter?

Advance 14LP Low Profile PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2017-02-13. It is manufactured by Cook Incorporated. The 510(k) number is K170193.

When was Advance 14LP Low Profile PTA Balloon Dilatation Catheter approved by the FDA?

Advance 14LP Low Profile PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2017-02-13, under approval number K170193.

What company makes Advance 14LP Low Profile PTA Balloon Dilatation Catheter?

Advance 14LP Low Profile PTA Balloon Dilatation Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Advance 14LP Low Profile PTA Balloon Dilatation Catheter?

The FDA product code for Advance 14LP Low Profile PTA Balloon Dilatation Catheter is LIT.

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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.

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