FDA Registration
Active
🇺🇸 United States
ATRION MEDICAL PRODUCTS, INC.
Reg #: 1043729
·
FEI: 1043729
·
Expires 2026
Products
11
Proprietary Names
30
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- ATRION MEDICAL PRODUCTS, INC.
- Registration Number
- 1043729
- FEI Number
- 1043729
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1426 CURT FRANCIS RD.
- City
- ARAB
- State
- AL
- ZIP
- 35016
- Country
- US
Regulatory Submissions
- 510(k) Number
- K962611
Owner / Operator
- Firm Name
- ATRION CORP.
- Operator Number
- 9914015
- Address
- ONE ALLENTOWN PKWY., --
- City
- Allen
- State
- TX
- Postal Code
- 75002
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2015-08-18 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2007-11-19 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2003-01-27 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2007-11-19 |
| Syringe, Balloon Inflation | MAV | Class 2 | Cardiovascular | No | 2007-11-19 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2012-12-19 |
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2013-01-24 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2007-11-19 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2007-11-19 |
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2018-01-09 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2007-11-19 |
Proprietary Names
QL 1015 Inflation Device; QL 1020 Inflation Device
QL Inflation Device
Atrion QL Inflation Device; Atrion QL Disposable Inflation Device; Atrion QL1030;
BD Eagle Inflation Device 20cc/30ATM REF 325130
BD Eagle Inflation Device 10cc/30ATM REF 325110
MISTER
QL Series Fluid Dispensing Syringes
QL Fluid Dispensing Syringe
Atrion QL Fluid Dispensing Syringe;
Atrion QL4515 Ref 96531
Atrion QL2530 Ref 96529
Atrion QL4515 REF 96518
Medtronic QL1430 REF 96473
Atrion QL6020 REF 96522
Atrion QL4515 Ref 96530
Atrion QL Inflation Device; Atrion QL Disposable Inflation Device QL2030
AQL1015 Inflation Device
QL 1020 Inflation Device
LB Medical QL1020
Atrion QL Inflation Device; Atrion QL Disposable Inflation Device; Atrion QL1015, QL1030;
NeedleVISE, 5 Port
NeedleVISE Sharps Securing System
Edwards Inflation Device REF 96402
Edwards Inflation Device REF 96417
QL Series Locking Syringes
QL Locking Syringe
Edwards Locking Syringe REF 96406
Atrion QL38X Locking Syringe Device REF 96527
NeedleVISE, Single Port
NeedleVISE; Atrion Large Bore Sharps Securing Device;
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device