Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
FDA 510(k) clearance K221339 · decided 2022-06-09
Clearance details
- K-number
- K221339
- Device name
- Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
- Applicant
- Contego Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-09
- Decision date
- 2022-06-09
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Raleigh, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard I (P240009/S005) | Contego Medical, Inc. | 2025-09-19 |
| Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection (P240009/S004) | Contego Medical, Inc. | 2025-08-22 |
| Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (P240009/S002) | Contego Medical, Inc. | 2024-11-15 |
| Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilatation Balloon System with Integrated Embolic Protection (P240009/S001) | Contego Medical, Inc. | 2024-11-15 |
| Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection (P240009) | Contego Medical, Inc. | 2024-10-11 |