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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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-12-14 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K163174.

When did Emerge PTCA Dilatation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Emerge PTCA Dilatation Catheter?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

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)

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.

K261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic IrelandK252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.K252295RyureiTerumo CorporationK251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, IrelandK242969Pantera Pro; Pantera LEOBiotronik, Inc.

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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