Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)
FDA 510(k) clearance K181128 · decided 2018-09-06
Clearance details
- K-number
- K181128
- Device name
- Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)
- Applicant
- Contego Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-04-30
- Decision date
- 2018-09-06
- Days to decision
- 129 days
- Clearance type
- Traditional
- 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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Recalls involving this device
No recalls on record reference this clearance.