VASCULAR SOLUTIONS DUETT SEALING DEVICE
FDA premarket approval P990037/S010 · decided 2002-04-30
Approval details
- PMA number
- P990037
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VASCULAR SOLUTIONS DUETT SEALING DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vascular Solutions, Inc.
- Date received
- 2002-02-27
- Decision date
- 2002-04-30
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR CHANGING THE SUPPLIER FROM COOK PHARMACEUTICALS TO CHESAPEAKE BIOLOGICAL LABORATORIES. THIS CHANGE WILL ALSO AFFECT THE APPROVED DILUENT. SPECIFICALLY, THE CURRENT APPROVED BUFFERING AGENT COMPONENT, 0.1% TROLAMINE NF (TEA) WILL BE CHANGED TO 0.1% TROMETHAMINE USP (TRIS).
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510(k) clearances by this applicant
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|---|---|---|
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| TrapLiner catheter (K180088) | Vascular Solutions, Inc. | 2018-04-04 |
| Warrior 14 guidewire (K180128) | Vascular Solutions, Inc. | 2018-02-16 |
| 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 |