Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ATRION MEDICAL QL INFLATION DEVICE

K-Number: K032840 · 2004-03-03

ApplicantAtrion Medical Products, Inc.
Decision Date2004-03-03
Product CodeKOE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ATRION MEDICAL QL INFLATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Atrion Medical Products, Inc.. It received FDA 510(k) clearance on 2004-03-03 under 510(k) number K032840. The device is classified under product code KOE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATRION MEDICAL QL INFLATION DEVICE?

ATRION MEDICAL QL INFLATION DEVICE is a medical device that received FDA 510(k) clearance on 2004-03-03. The listed applicant is Atrion Medical Products, Inc.. The 510(k) number is K032840.

When did ATRION MEDICAL QL INFLATION DEVICE receive FDA 510(k) clearance?

ATRION MEDICAL QL INFLATION DEVICE received FDA 510(k) clearance on 2004-03-03, under 510(k) number K032840.

Who is the listed applicant for ATRION MEDICAL QL INFLATION DEVICE?

The FDA 510(k) record lists Atrion Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATRION MEDICAL QL INFLATION DEVICE?

The FDA product code for ATRION MEDICAL QL INFLATION DEVICE is KOE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Atrion Medical Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K060643QL LOCKING SYRINGEK043249ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICEK041158ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEMK020333ATRION MEDICAL QL FLUID DISPENSING SYRINGEK973633ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SETK973872ATRION MEDICAL COATED LACRIMAL INTUBATION SET

View all 9 devices →

Related Devices (Code: KOE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.K972964ATRION MEDICAL BALLOON CATHETER INFLATION DEVICEAtrion Medical Products, Inc.K962611BARD EAGLE INFLATION DEVICERyder Intl. Corp.K961904AQ HYDROPHILIC DILATORSCook Urological, Inc.K924440U.S. MEDICAL PS-7000 DIALYSIS SCALEU.S. Medical Corp.K920551120 FR OPTILUME PROSTATE BALLOON DILATORAmerican Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑