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FDA 510(k)

Emerge Monorail PTCA Dilatation Catheter

K-Number: K220629 · 2022-03-24

ApplicantBoston Scientific
Decision Date2022-03-24
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Emerge Monorail PTCA Dilatation Catheter is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2022-03-24 under approval number K220629. 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 Monorail PTCA Dilatation Catheter?

Emerge Monorail PTCA Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-03-24. It is manufactured by Boston Scientific. The 510(k) number is K220629.

When was Emerge Monorail PTCA Dilatation Catheter approved by the FDA?

Emerge Monorail PTCA Dilatation Catheter received FDA 510(k) clearance on 2022-03-24, under approval number K220629.

What company makes Emerge Monorail PTCA Dilatation Catheter?

Emerge Monorail PTCA Dilatation Catheter is manufactured by Boston Scientific.

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

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

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Related Devices (Code: LOX)

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation CatheteBoston Scientific Corporation K163174Emerge PTCA Dilatation CatheterBoston 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

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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