Selethru(TM) NC PTCA Balloon Dilatation Catheter— 510(k) K211393

Name: FDA 510(k) clearance K211393
Creator: U.S. Food and Drug Administration
Published: 2021-07-02

Substantially Equivalent

Kossel Medtech (Suzhou) Co., Ltd.

FDA 510(k) clearance K211393 for Selethru(TM) NC PTCA Balloon Dilatation Catheter, Substantially Equivalent on 2021-07-02. Applicant: Kossel Medtech (Suzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Kossel Medtech (Suzhou) Co., Ltd.
Product code: Code LOX
Device class: Class 2
Regulation: 21 CFR 870.5100
Advisory panel: Cardiovascular
Date received: 2021-05-05
Decision date: 2021-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code LOX

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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

More clearances from Kossel Medtech (Suzhou) Co., Ltd.

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K254212 — NC PTA Balloon Dilatation Catheter2026-09-16
K231402 — HP PTA Balloon Dilatation Catheter2023-12-20
K221245 — PTA Balloon Dilatation Catheter2022-12-14
K211349 — Selebrek PTCA Balloon Dilatation Catheter2022-01-07
K182699 — Selethru PTCA Balloon Dilatation Catheter2018-11-26

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.