CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)— 510(k) K872485

Clearance details

Applicant

Ideas For Medicine, Inc.

Product code

Code DXE

Device class

Class 2

Regulation

21 CFR 870.5150

Advisory panel

Cardiovascular

Date received

1987-06-22

Decision date

1987-08-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Clearwater, FL, US

• K240078 — Fogarty Thru-Lumen Embolectomy Catheter2024-08-28
• K241330 — Fogarty Fortis Arterial Embolectomy Catheter2024-07-02
• K233819 — Fogarty Venous Thrombectomy Catheters2024-05-22
• K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve2024-05-22
• K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters2024-05-20

• K961883 — VERSA-CATH ARTERIAL CATHETER1997-01-13
• K962751 — IDEAS' DUAL PORT1996-09-30
• K961716 — VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE1996-09-19
• K960715 — PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F1996-09-09
• K960422 — PRUITT SAFETY OCCLUSION CATHETER1996-08-07

Death

27

Injury

258

Malfunction

2,266

Total

2,551

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 →