Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| H/S Elliptosphere™ Catheter • 5 French | 61-4005 | Coopersurgical, Inc. | LKF | 60888937016446 |
| H/S Elliptosphere™ Catheter with Integrated Stylet | 61-4005S | Coopersurgical, Inc. | LKF | 60888937016453 |