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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 a medical device manufactured by KANEKA Corporation. It received FDA 510(k) clearance on 2017-04-07 under approval 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. It is manufactured by KANEKA Corporation. The 510(k) number is K163372.

When was RX Takeru Balloon Dilatation Catheter approved by the FDA?

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

What company makes RX Takeru Balloon Dilatation Catheter?

RX Takeru Balloon Dilatation Catheter is manufactured by KANEKA Corporation.

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

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

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Other Devices by KANEKA Corporation

K160004Crosstella OTW K160013Crosperio OTW K152887Crosperio RX PTA Balloon Dilatation Catheter K152873Crosstella RX Balloon Dilatation Catheter K170941RX NC Takeru PTCA Balloon Dilatation Catheter K163479R2P Metacross RX

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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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