VASCULAR SOLUTION DUETT SEALING DEVICE
FDA premarket approval P990037/S008 · decided 2002-05-29
Approval details
- PMA number
- P990037
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VASCULAR SOLUTION DUETT SEALING DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vascular Solutions, Inc.
- Date received
- 2001-12-11
- Decision date
- 2002-05-29
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE DELIVERY CANNULAE AND THE PROCOAGULANT AND CHANGING THE BUFFERING AGENT IN THE DILUTENT TO TROMETHAMINE USP (TRIS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DUETT FLOWABLE HEMOSTAT DEVICE AND IS INDICATED FOR USE AS ADJUNCT TREATMENT IN OBTAINING HEMOSTASIS IN SEALING RESIDUAL OOZING OF TISSUE TRACTS OF FEMORAL ACCESS SITES THAT HAVE BEEN PREVIOUSLY CLOSED BY SUTURE MEDIATED/COLLAGEN-BASED HEMOSTATIC DEVICES.
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510(k) clearances by this applicant
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|---|---|---|
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| Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume (K173891) | Vascular Solutions, Inc. | 2018-01-19 |
| Raider Guidewire (K173532) | Vascular Solutions, Inc. | 2017-12-15 |
| Octane aspiration system (K173266) | Vascular Solutions, Inc. | 2017-12-01 |