Closer Vascular Sealing System (VSS)
FDA premarket approval P150022/S003 · decided 2018-01-31
Approval details
- PMA number
- P150022
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Closer Vascular Sealing System (VSS)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Rex Medical, L.P.
- Date received
- 2017-11-02
- Decision date
- 2018-01-31
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval for design changes to the delivery system as well as packaging changes to the delivery system and access kit.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Revolution Peripheral Atherectomy System (K212351) | Rex Medical, L.P. | 2021-12-15 |
| Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire (K191419) | Rex Medical, L.P. | 2019-09-12 |
| Rex Medical Aspiration Pump (K173389) | Rex Medical, L.P. | 2018-01-30 |
| Option (TM) ELITE Vena Cava Filter 100cm System (K143405) | Rex Medical, L.P. | 2015-04-16 |
| CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K141617) | Rex Medical, L.P. | 2014-11-14 |
| OPTION ELITE VENA CAVA FILTER SYSTEM (K133243) | Rex Medical, L.P. | 2013-12-17 |
| CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K060904) | Rex Medical, L.P. | 2006-04-28 |
| MODIFICATION TO SHORT INTRODUCER SHEATH (K042399) | Rex Medical, L.P. | 2004-12-17 |