VASCULAR SOLUTIONS DUETT SEALING DEVICE
FDA premarket approval P990037/S014 · decided 2003-03-14
Approval details
- PMA number
- P990037
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VASCULAR SOLUTIONS DUETT SEALING DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vascular Solutions, Inc.
- Date received
- 2003-02-24
- Decision date
- 2003-03-14
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR AN ADDITIONAL INCOMING INSPECTION REQUIREMENT TO MEASURE THE OUTER DIAMETER (OD) OF THE DISTAL END OF THE STOPCOCK AND TO TIGHTEN THE TOLERANCE AROUND THE ORIGINALLY APPROVED OD ON THE STOPCOCK DISTAL END.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |