CLOSER VASCULAR SEALING SYSTEM
FDA premarket approval P150022 · decided 2016-02-12
Approval details
- PMA number
- P150022
- Trade name
- CLOSER VASCULAR SEALING SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Rex Medical, L.P.
- Date received
- 2015-06-25
- Decision date
- 2016-02-12
- Days to decision
- 232 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval for the Closer Vascular Sealing System (VSS). This device is indicated for the percutaneous closure of femoral artery access sites while reducing times to hemostasis and ambulation as compared to Performance Goals in patients who have undergone diagnostic or interventional endovascular procedures utilizing 5, 6 and 7 Fr procedural sheaths.
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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 |