Cleared Traditional

Ebony HP PTA OTW 0.035 Catheter

K220410 · Natec Medical , Ltd. · Cardiovascular
Jun 2022
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K220410 is an FDA 510(k) clearance for the Ebony HP PTA OTW 0.035 Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Natec Medical , Ltd. (Reduit, MU). The FDA issued a Cleared decision on June 29, 2022, 135 days after receiving the submission on February 14, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K220410 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2022
Decision Date June 29, 2022
Days to Decision 135 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

Similar Devices — LIT Catheter, Angioplasty, Peripheral, Transluminal

All 401
Armada? 14 NC PTA Catheter
K252512 · Abbott Medical · Feb 2026
Amethyst HP PTA OTW 0.035 Catheter
K251915 · Natec Medical , Ltd. · Dec 2025
Passeo-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) Catheter
K250706 · Biotronik, Inc. · Apr 2025
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
K243704 · Brosmed Medical Co., Ltd. · Feb 2025
Amethyst HP PTA OTW 0.035 Catheter
K241040 · Natec Medical , Ltd. · Dec 2024
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
K242419 · Creagh Medical Ltd. Dba Surmodics, Inc. · Nov 2024