DIAGNOSTIC DUETT
FDA premarket approval P990037/S001 · decided 2001-11-02
Approval details
- PMA number
- P990037
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIAGNOSTIC DUETT
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vascular Solutions, Inc.
- Date received
- 2000-10-04
- Decision date
- 2001-11-02
- Days to decision
- 394 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE CHANGE IN DILUENT AND PROCOAGULANT COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIAGNOSTIC DUETT AND IS INDICATED FOR SEALING FEMORAL ARTERIAL PUNCTURE SITES AND REDUCING TIME TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES USING A 5F-9F INTRODUCER SHEATH WITH AN OVERALL LENGTH NOT EXCEEDING 15.2 CM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Octane Mechanical Thrombectomy System (K182232) | Vascular Solutions, Inc. | 2018-09-11 |
| Bandit guidewire (K181647) | Vascular Solutions, Inc. | 2018-07-20 |
| VSI Micro-Introducer Kit (K180913) | Vascular Solutions, Inc. | 2018-05-09 |
| 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 |