Microcatheter
FDA 510(k) clearance K232647 · decided 2023-09-29
Clearance details
- K-number
- K232647
- Device name
- Microcatheter
- Applicant
- Surmodics,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-31
- Decision date
- 2023-09-29
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SurVeil Drug-Coated Balloon (P210025/S006) | Surmodics,Inc. | 2025-06-06 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S005) | Surmodics,Inc. | 2024-12-20 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S004) | Surmodics,Inc. | 2024-08-20 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S003) | Surmodics,Inc. | 2024-07-02 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S002) | Surmodics,Inc. | 2024-02-29 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S001) | Surmodics,Inc. | 2024-01-03 |
| SurVeil Drug-Coated Balloon (P210025) | Surmodics,Inc. | 2023-06-16 |