FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
K Number: K221339
·
Decision Jun 9, 2022
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
5
Review Days
31
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Basic Information
- Device Name
- Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
- K Number
- K221339
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Contego Medical, Inc.
- Date Received
- May 9, 2022
- Decision Date
- June 9, 2022
- Product Code
- LIT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
| K251485 | Excipio LV Prime Thrombectomy Device | Jun 13, 2025 | Substantially Equivalent |
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| K221204 | Excipio SV Thrombectomy Device | Jun 23, 2022 | Substantially Equivalent |