OPN NC PTCA Dilatation Catheter— 510(k) K212393

Name: FDA 510(k) clearance K212393
Creator: U.S. Food and Drug Administration
Published: 2022-03-14

Substantially Equivalent

Sis Medical AG

FDA 510(k) clearance K212393 for OPN NC PTCA Dilatation Catheter, Substantially Equivalent on 2022-03-14. Applicant: Sis Medical AG. Device class: 2.

Clearance details

Applicant: Sis Medical AG
Product code: Code LOX
Device class: Class 2
Regulation: 21 CFR 870.5100
Advisory panel: Cardiovascular
Date received: 2021-08-02
Decision date: 2022-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frauenfeld, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code LOX

view all

K261428 — NC Euphora Rapid Exchange Balloon Dilatation Catheter2026-08-14
K261759 — Euphora Rapid Exchange (RX) Balloon Dilatation Catheter2026-07-27
K252116 — Firefighter Pro PTCA Balloon Catheter2026-04-07
K254022 — FLASH Flex Aorto-Ostial Angioplasty System2026-04-02
K252295 — Ryurei2026-03-27

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.