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FDA 510(k)

Crosstella OTW

K-Number: K160004 · 2016-04-29

ApplicantKANEKA Corporation
Decision Date2016-04-29
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Crosstella OTW is the device name listed in this FDA 510(k) record. The listed applicant is KANEKA Corporation. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K160004. 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 OTW?

Crosstella OTW is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is KANEKA Corporation. The 510(k) number is K160004.

When did Crosstella OTW receive FDA 510(k) clearance?

Crosstella OTW received FDA 510(k) clearance on 2016-04-29, under 510(k) number K160004.

Who is the listed applicant for Crosstella OTW?

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 Crosstella OTW?

The FDA product code for Crosstella OTW is LIT.

Related Clinical Trials

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NCT07687472Post-Market Clinical Follow-up Study of i-ED Coil and EDG v4 for Arteriovenous MalformationNOT_YET_RECRUITING

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 CatheterK163372RX Takeru Balloon Dilatation CatheterK163479R2P Metacross RXK160013Crosperio OTWK152887Crosperio RX PTA Balloon Dilatation Catheter

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Related Devices (Code: LIT)

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.

K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.

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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