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FDA 510(k)

RX Takeru Balloon Dilatation Catheter

K-Number: K163372 · 2017-04-07

ApplicantKANEKA Corporation
Decision Date2017-04-07
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RX Takeru Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is KANEKA Corporation. It received FDA 510(k) clearance on 2017-04-07 under 510(k) number K163372. 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 RX Takeru Balloon Dilatation Catheter?

RX Takeru Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2017-04-07. The listed applicant is KANEKA Corporation. The 510(k) number is K163372.

When did RX Takeru Balloon Dilatation Catheter receive FDA 510(k) clearance?

RX Takeru Balloon Dilatation Catheter received FDA 510(k) clearance on 2017-04-07, under 510(k) number K163372.

Who is the listed applicant for RX Takeru Balloon Dilatation Catheter?

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

What is the FDA product code for RX Takeru Balloon Dilatation Catheter?

The FDA product code for RX Takeru Balloon Dilatation Catheter is LOX.

Related Clinical Trials

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Other records listing KANEKA Corporation as applicant

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.

K172264OTW Takeru PTCA Balloon Dilatation CatheterK170941RX NC Takeru PTCA Balloon Dilatation CatheterK163479R2P Metacross RXK160013Crosperio OTWK160004Crosstella OTWK152887Crosperio RX PTA Balloon Dilatation Catheter

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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.

K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic IrelandK261759Euphora 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, Ireland

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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