HEMOCATH REPAIR KIT— 510(k) K840424

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K840424 for HEMOCATH REPAIR KIT, Substantially Equivalent on 1984-03-05. Applicant: Quinton, Inc.. Device class: 2.

Clearance details

Applicant: Quinton, Inc.
Product code: Code KNZ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1984-02-01
Decision date: 1984-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNZ

K842039 — ARGON DUAL LUMEN HEMODIALYSIS, CATHETER1985-01-29
K844612 — ACUTE HEMODIALYSIS TRAYS1984-12-17
K842864 — VACCESS FEMORAL CANNULA1984-08-08
K842416 — DUO FLOW CATHETER-MC 541984-07-26
K841530 — DOUBLE LUMEN SUBLCAVIAN-FEMORAL1984-06-25

More clearances from Quinton, Inc.

K032038 — PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 926012003-09-05
K021906 — QUINTON Q-CATH, MODEL 0004602002-09-04
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

Data sourced from openFDA. This site is unofficial and independent of the FDA.