White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter— 510(k) K162448

Clearance details

Applicant

Cook Incorporated

Product code

Code DQO

Device class

Class 2

Regulation

21 CFR 870.1200

Advisory panel

Cardiovascular

Date received

2016-09-01

Decision date

2017-05-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bloomington, IN, US

• K261455 — Arterial Pressure Monitoring Set/Tray2026-06-26
• K252702 — Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N2026-05-28
• K254278 — Arterial Pressure Monitoring Set/Tray2026-03-25
• K250751 — DualView Catheter2025-07-17
• K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter2025-01-31

• 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

35

Injury

993

Malfunction

1,772

Other

5

Total

2,805

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-1935-2026 — Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).Class I·Ongoing·Cook Incorporated·20260402

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162448.