MANTA Vascular Closure Device
FDA premarket approval P180025 · decided 2019-02-01
Approval details
- PMA number
- P180025
- Trade name
- MANTA Vascular Closure Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Teleflex Medical, LLC
- Date received
- 2018-07-09
- Decision date
- 2019-02-01
- Days to decision
- 207 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Morrisville, NC
- Statement
- Approval for the 14F MANTA Vascular Closure Device. The device is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the 18F MANTA Vascular Closure Device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths (maximum OD/profile of 25F).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture (K261988) | Teleflex Medical, LLC | 2026-07-09 |
| Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ (K260775) | Teleflex Medical, LLC | 2026-05-06 |