Crosperio OTW— 510(k) K160013

Name: FDA 510(k) clearance K160013
Creator: U.S. Food and Drug Administration
Published: 2016-04-29

Substantially Equivalent

KANEKA Corporation

FDA 510(k) clearance K160013 for Crosperio OTW, Substantially Equivalent on 2016-04-29. Applicant: KANEKA Corporation. Device class: 2.

Clearance details

Applicant: KANEKA Corporation
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2016-01-04
Decision date: 2016-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIT

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K260304 — WAVE PTA Balloon Catheter2026-05-20
K252512 — Armada 14 NC PTA Catheter2026-02-13
K251915 — Amethyst HP PTA OTW 0.035 Catheter2025-12-18
K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter +5 more2025-04-04
K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter +2 more2025-02-27

More clearances from KANEKA Corporation

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K172264 — OTW Takeru PTCA Balloon Dilatation Catheter2018-03-19
K170941 — RX NC Takeru PTCA Balloon Dilatation Catheter2017-07-07
K163372 — RX Takeru Balloon Dilatation Catheter2017-04-07
K163479 — R2P Metacross RX2017-01-11
K160004 — Crosstella OTW2016-04-29

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.