Cleared Traditional

K152873 - Crosstella RX Balloon Dilatation Catheter

K152873 is an FDA 510(k) clearance for Crosstella RX Balloon Dilatation Catheter, manufactured by KANEKA Corporation. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K152873 · KANEKA Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
114d
Days
Class 2
Risk

K152873 is an FDA 510(k) clearance for the Crosstella RX Balloon Dilatation Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by KANEKA Corporation (Tokyo, JP). The FDA issued a Cleared decision on January 22, 2016 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all KANEKA Corporation devices

FDA 510(k) Submission Details - K152873

510(k) Number K152873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2015
Decision Date January 22, 2016
Days to Decision 114 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Quintiles Consulting
CHRISTOPHER M SLOAN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 374
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K152873.
Crosstella OTW
K160004 · KANEKA Corporation · Apr 2016
Crosperio OTW
K160013 · KANEKA Corporation · Apr 2016
MMS PTA Balloon Catheter
K152934 · Micro Medical Solutions, Inc. · Apr 2016
Crosperio RX PTA Balloon Dilatation Catheter
K152887 · KANEKA Corporation · Jan 2016
Cronus HP - High Pressure Peripheral Balloon Catheter
K151141 · Nipro Medical Corporation · Jan 2016
PolarCath Peripheral Dilatation System
K152665 · Nucyro Vascular, LLC · Oct 2015