Jade PTA Balloon Dilatation Catheter— 510(k) K173894

Name: FDA 510(k) clearance K173894
Creator: U.S. Food and Drug Administration
Published: 2018-02-09

Substantially Equivalent

Orbusneich Medical Trading, Inc.

FDA 510(k) clearance K173894 for Jade PTA Balloon Dilatation Catheter, Substantially Equivalent on 2018-02-09. Applicant: Orbusneich Medical Trading, Inc.. Device class: 2.

Clearance details

Applicant: Orbusneich Medical Trading, Inc.
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2017-12-21
Decision date: 2018-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

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K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter +2 more2025-02-27

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K200269 — Sapphire II PRO2020-03-04
K192344 — Sapphire NC Plus Coronary Dilatation Catheter2019-09-19
K182713 — Scoreflex PTA Scoring Balloon Catheter2019-06-11
K182360 — Teleport Microcatheter2018-11-09
K180921 — Sapphire II PRO Balloon Dilatation Catheter2018-06-28

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.