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FDA 510(k)

Emerge PTCA Dilatation Catheter

K-Number: K163174 · 2016-12-14

ApplicantBoston Scientific Corporation
Decision Date2016-12-14
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Emerge PTCA Dilatation Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-12-14 under approval number K163174. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Emerge PTCA Dilatation Catheter?

Emerge PTCA Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2016-12-14. It is manufactured by Boston Scientific Corporation. The 510(k) number is K163174.

When was Emerge PTCA Dilatation Catheter approved by the FDA?

Emerge PTCA Dilatation Catheter received FDA 510(k) clearance on 2016-12-14, under approval number K163174.

What company makes Emerge PTCA Dilatation Catheter?

Emerge PTCA Dilatation Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for Emerge PTCA Dilatation Catheter?

The FDA product code for Emerge PTCA Dilatation Catheter is LOX.

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Related Devices (Code: LOX)

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation CatheteBoston Scientific Corporation K160985Pantera ProBiotronik, Inc. K162209Sapphire NC PlusOrbusneich Medical, Inc. K153742Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited K153682Chocolate XD PTCA Balloon CatheterTrireme Medical, LLC

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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