Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™
FDA 510(k) clearance K260775 · decided 2026-05-06
Clearance details
- K-number
- K260775
- Device name
- Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™
- Applicant
- Teleflex Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2026-03-10
- Decision date
- 2026-05-06
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- GAT
- Device class
- 2
- Regulation number
- 878.5000
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Morrisville, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MANTA Vascular Closure Device; MANTA Vascular Closure Device, 18F; MANTA Vascular Closure Device, 14F; MANTA SF Depth L (P180025/S014) | Teleflex Medical, LLC | 2025-08-05 |
| MANTA Vascular Closure Device (P180025/S013) | Teleflex Medical, LLC | 2025-01-03 |
| MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator (P180025/S012) | Teleflex Medical, LLC | 2024-06-07 |
| MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator (P180025/S011) | Teleflex Medical, LLC | 2024-03-06 |
| MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator (P180025/S010) | Teleflex Medical, LLC | 2023-10-11 |
| MANTA Vascular Closure Device (P180025/S009) | Teleflex Medical, LLC | 2021-04-19 |
| MANTA Vascular Closure Device (P180025/S008) | Teleflex Medical, LLC | 2020-09-18 |
| MANTA Vascular Closure Device (P180025/S007) | Teleflex Medical, LLC | 2020-05-26 |