ATRION MEDICAL QL INFLATION DEVICE— 510(k) K032840

Name: FDA 510(k) clearance K032840
Creator: U.S. Food and Drug Administration
Published: 2004-03-03

Substantially Equivalent

Atrion Medical Products, Inc.

FDA 510(k) clearance K032840 for ATRION MEDICAL QL INFLATION DEVICE, Substantially Equivalent on 2004-03-03. Applicant: Atrion Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Atrion Medical Products, Inc.
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 2003-09-11
Decision date: 2004-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arab, AL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOE

view all

K191061 — Optilume Basic Urological Balloon Dilation Catheter2020-01-02
K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE1997-10-10
K962611 — BARD EAGLE INFLATION DEVICE1996-10-21
K961904 — AQ HYDROPHILIC DILATORS1996-10-18
K924440 — U.S. MEDICAL PS-7000 DIALYSIS SCALE1993-05-26

More clearances from Atrion Medical Products, Inc.

view all

K060643 — QL LOCKING SYRINGE2006-07-12
K043249 — ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE2005-05-25
K041158 — ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM2004-06-16
K020333 — ATRION MEDICAL QL FLUID DISPENSING SYRINGE2002-04-25
K973633 — ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET1998-01-16

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