CLOSER VASCULAR SEALING SYSTEM
FDA premarket approval P150022/S002 · decided 2016-11-10
Approval details
- PMA number
- P150022
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLOSER VASCULAR SEALING SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Rex Medical, L.P.
- Date received
- 2016-08-15
- Decision date
- 2016-11-10
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval to implement minor design modifications to the production sheath cap.
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510(k) clearances by this applicant
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|---|---|---|
| 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 |