Data / Medical devices / United States / Atrion Medical Products, Inc.
Atrion Medical Products, Inc.: FDA-registered device maker in Arab, AL, United States, 10 510(k) clearances
Atrion Medical Products, Inc. is registered with the FDA (registration 1043729) in Arab, AL, United States. It lists 11 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 12, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1043729
- Address
- 1426 Curt Francis RD., Arab, AL, United States, 35016
- Owner or operator
- ATRION CORP. (9914015)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 27, 2003
- Registered through
- 2026
- Brand names listed
- AQL1015 Inflation Device, Atrion QL Fluid Dispensing Syringe;, Atrion QL Inflation Device; Atrion QL Disposable Inflation Device QL2030, Atrion QL Inflation Device; Atrion QL Disposable Inflation Device; Atrion QL1015, QL1030;, Atrion QL Inflation Device; Atrion QL Disposable Inflation Device; Atrion QL1030;, Atrion QL2530 Ref 96529, Atrion QL38X Locking Syringe Device REF 96527, Atrion QL4515 REF 96518 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anesthesia Conduction Kit | CAZ | 2 | Manufacturer | accessdata.fda.gov |
| Bronchoscope Accessory | KTI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Device, Neurovascular Embolization | HCG | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dilator, Lachrymal | HNW | 1 | Manufacturer | accessdata.fda.gov |
| Dilator, Urethral | KOE | 2 | Manufacturer | accessdata.fda.gov |
| Injector And Syringe, Angiographic | DXT | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Contract manufacturer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Balloon Inflation | MAV | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Balloon Inflation, Exempt | PTM | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2009 | K090660 | AIRWAY BALLOON CATHETER INFLATION DEVICE | KTI | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| May 2, 2008 | K080967 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT | HCG | Substantially Equivalent | Cordis Neurovascular, Inc. | accessdata.fda.gov |
| July 12, 2006 | K060643 | QL LOCKING SYRINGE | MAV | Substantially Equivalent | Atrion Medical Products, Inc. | accessdata.fda.gov |
| May 25, 2005 | K043249 | ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE | FMI | Substantially Equivalent | Atrion Medical Products, Inc. | accessdata.fda.gov |
| June 16, 2004 | K041158 | ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM | CAZ | Substantially Equivalent | Atrion Medical Products, Inc. | accessdata.fda.gov |
| March 3, 2004 | K032840 | ATRION MEDICAL QL INFLATION DEVICE | KOE | Substantially Equivalent | Atrion Medical Products, Inc. | accessdata.fda.gov |
| April 25, 2002 | K020333 | ATRION MEDICAL QL FLUID DISPENSING SYRINGE | DXT | Substantially Equivalent | Atrion Medical Products, Inc. | accessdata.fda.gov |
| October 10, 1997 | K972964 | ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE | KOE | Substantially Equivalent | Atrion Medical Products, Inc. | accessdata.fda.gov |
| October 21, 1996 | K962611 | BARD EAGLE INFLATION DEVICE | KOE | Substantially Equivalent | Ryder Intl. Corp. | accessdata.fda.gov |
| April 17, 1996 | K953522 | USCI IDEAL PTCA KIT | MAV | Substantially Equivalent | Ryder Intl. Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Anesthesia Conduction Kit
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Balloon Inflation
- All makers of Lavage, Jet
- All makers of Dilator, Urethral
- All makers of Syringe, Balloon Inflation, Exempt
Updated June 12, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.