Brosmed Medical Co., Ltd.

• LIT — Cardiovascular4 devices
• LOX — Cardiovascular3 devices
• PNO — Cardiovascular1 device

• Z-0963-2019 — Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.Class II·Terminated·2018-12-14

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter +2 moreCode LIT·2025-02-27
• K241478 — Tri-Wedge PTA Scoring Balloon Dilatation CatheterCode PNO·2024-10-22
• K230705 — POT PTCA Balloon Dilatation CatheterCode LOX·2023-04-11
• K212215 — Tiche PTA Balloon Dilatation CatheterCode LIT·2022-07-19
• K203390 — Artimes pro Balloon Dilatation CatheterCode LOX·2021-04-14
• K160941 — Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterCode LIT·2016-12-13
• K153742 — Apollo Balloon Dilatation CatheterCode LOX·2016-08-08
• K160256 — Polux , Minerva and Atropos PTA Balloon Dilatation CatheterCode LIT·2016-07-29