| ||||||||||||||||||||||||||
FDA 510(k) Applications for Medical Device Product Code "KOE"
|
||||||||||||||||||||||||||
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K972964 | ATRION MEDICAL PRODUCTS, INC. | ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE | 10/10/1997 |
| K032840 | ATRION MEDICAL PRODUCTS, INC. | ATRION MEDICAL QL INFLATION DEVICE | 03/03/2004 |
| K961904 | COOK UROLOGICAL, INC. | AQ HYDROPHILIC DILATORS | 10/18/1996 |
| K962611 | RYDER INTL. CORP. | BARD EAGLE INFLATION DEVICE | 10/21/1996 |
| K191061 | Urotronic Inc | Optilume Basic Urological Balloon Dilation Catheter | 01/02/2020 |