CrossCath Support Catheter— 510(k) K161801

Clearance details

Applicant

Cook Incorporated

Product code

Code KRA

Device class

Class 2

Regulation

21 CFR 870.1210

Advisory panel

Cardiovascular

Date received

2016-06-30

Decision date

2016-07-29

Decision

Substantially Equivalent

Clearance type

Special

Location

Bloomington, IN, US

• K254051 — Extroducer Infusion Catheter System2026-09-11
• K261610 — Verge Microcatheter2026-06-11
• K260771 — TruSelect 2.6 Microcatheter2026-05-15
• K250794 — InVera Infusion Device2026-03-12
• K243534 — Micro Catheter2025-07-30

• K233177 — Nest VT Vitrification Device2024-03-08
• K222254 — Gunther Tulip Vena Cava Filter Retrieval Set2023-05-16
• K223098 — Bakri Essential Postpartum Balloon2022-10-28
• K210734 — Endovascular Dilator and Sets2021-04-06
• K203670 — Extra Large Check-Flo Introducer2021-02-16

Death

234

Injury

1,029

Malfunction

3,012

Other

2

Total

4,277

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 →

• Z-0587-2020 — CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.Class I·Terminated·Cook Inc.·20191108
• Z-0588-2020 — CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.Class I·Terminated·Cook Inc.·20191108
• Z-0589-2020 — CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.Class I·Terminated·Cook Inc.·20191108
• Z-0590-2020 — CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.Class I·Terminated·Cook Inc.·20191108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161801.