VENASEAL CLOSURE SYSTEM
FDA premarket approval P140018 · decided 2015-02-20
Approval details
- PMA number
- P140018
- Trade name
- VENASEAL CLOSURE SYSTEM
- Generic name
- Agent, occluding, vascular, permanent
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2014-08-25
- Decision date
- 2015-02-20
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- PJQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE VENASEAL CLOSURE SYSTEM. THIS DEVICE IS INDICATED FOR THE PERMANENT CLOSURE OF LOWER EXTREMITY SUPERFICIAL TRUNCAL VEINS, SUCH AS THE GREAT SAPHENOUS VEIN (GSV), THROUGH ENDOVASCULAR EMBOLIZATION WITH COAPTATION. VENASEAL IS INTENDED FOR USE IN ADULTS WITH CLINICALLY SYMPTOMATIC VENOUS REFLUX AS DIAGNOSED BY DUPLEX ULTRASOUND (DUS).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
| Sentrant Introducer Sheath with Hydrophilic Coating (K171866) | Medtronic Vascular, Inc. | 2017-12-20 |
| SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System (K170191) | Medtronic Vascular, Inc. | 2017-06-16 |
| Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (K171427) | Medtronic Vascular, Inc. | 2017-06-13 |
| HawkOne Directional Atherectomy System (K161361) | Medtronic Vascular, Inc. | 2016-10-14 |