QUINTON Q-CATH, MODEL 000460— 510(k) K021906

Name: FDA 510(k) clearance K021906
Creator: U.S. Food and Drug Administration
Published: 2002-09-04

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K021906 for QUINTON Q-CATH, MODEL 000460, Substantially Equivalent on 2002-09-04. Applicant: Quinton, Inc.. Device class: 2.

Clearance details

Applicant: Quinton, Inc.
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2002-06-10
Decision date: 2002-09-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQK

view all

K253692 — AVVIGO+ Multi-Modality Guidance System2026-08-21
K262005 — Affera Integrated Mapping System2026-08-21
K253576 — CorVista System® with PCWP Add-On2026-07-26
K262006 — EnSite X EP System2026-07-15
K252978 — ScioCardio ECG Analysis Platform2026-07-09

More clearances from Quinton, Inc.

view all

K032038 — PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 926012003-09-05
K003576 — Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 0005032001-01-25
K001492 — QUINTON Q-STRESS, MODEL 0004832000-08-09
K992908 — Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)2000-03-06
K990866 — QUINTON MEDTRACK CR PLUS TREADMILL1999-04-29

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.