Sapphire II PRO Balloon Dilatation Catheter— 510(k) K180921

Name: FDA 510(k) clearance K180921
Creator: U.S. Food and Drug Administration
Published: 2018-06-28

Substantially Equivalent

Orbusneich Medical Trading, Inc.

FDA 510(k) clearance K180921 for Sapphire II PRO Balloon Dilatation Catheter, Substantially Equivalent on 2018-06-28. Applicant: Orbusneich Medical Trading, Inc.. Device class: 2.

Clearance details

Applicant: Orbusneich Medical Trading, Inc.
Product code: Code LOX
Device class: Class 2
Regulation: 21 CFR 870.5100
Advisory panel: Cardiovascular
Date received: 2018-04-09
Decision date: 2018-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Orbusneich Medical Trading, Inc.

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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
K173680 — Sapphire II PRO2018-03-01

Adverse events under product code LOX

product code LOX

Death: 190
Injury: 1,498
Malfunction: 9,670
Total: 11,358

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.