The following data is part of a premarket notification filed by Contego Medical Inc. with the FDA for Paladin Carotid Post-dilation Balloon System With Integrated Embolic Protection.
| Device ID | K221339 |
| 510k Number | K221339 |
| Device Name: | Paladin Carotid Post-Dilation Balloon System With Integrated Embolic Protection |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Contego Medical Inc. 3801 Lake Boone Trail, Suite 100 Raleigh, NC 27607 |
| Contact | Jim Clossick |
| Correspondent | Jim Clossick Contego Medical Inc. 3801 Lake Boone Trail, Suite 100 Raleigh, NC 27607 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-09 |
| Decision Date | 2022-06-09 |