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FDA 510(k)

Crosstella RX Balloon Dilatation Catheter

K-Number: K152873 · 2016-01-22

ApplicantKANEKA Corporation
Decision Date2016-01-22
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Crosstella RX Balloon Dilatation Catheter is a medical device manufactured by KANEKA Corporation. It received FDA 510(k) clearance on 2016-01-22 under approval number K152873. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Crosstella RX Balloon Dilatation Catheter?

Crosstella RX Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2016-01-22. It is manufactured by KANEKA Corporation. The 510(k) number is K152873.

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

Crosstella RX Balloon Dilatation Catheter received FDA 510(k) clearance on 2016-01-22, under approval number K152873.

What company makes Crosstella RX Balloon Dilatation Catheter?

Crosstella RX Balloon Dilatation Catheter is manufactured by KANEKA Corporation.

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

The FDA product code for Crosstella RX Balloon Dilatation Catheter is LIT.

Related Clinical Trials

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Other Devices by KANEKA Corporation

K160004Crosstella OTW K160013Crosperio OTW K152887Crosperio RX PTA Balloon Dilatation Catheter K170941RX NC Takeru PTCA Balloon Dilatation Catheter K163372RX Takeru Balloon Dilatation Catheter K163479R2P Metacross RX

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Related Devices (Code: LIT)

K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K162316Pirouette 014Arravasc, Ltd. K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018Boston Scientific Corporation K161427Pirouette 035Arravasc Limited K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160004Crosstella OTWKANEKA Corporation

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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