VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
FDA premarket approval P990037/S025 · decided 2007-07-17
Approval details
- PMA number
- P990037
- Supplement
- S025
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vascular Solutions, Inc.
- Date received
- 2007-06-14
- Decision date
- 2007-07-17
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE ADDITION OF THE FOLLOWING WARNING TO THE LABELING: ?THE SAFETY AND EFFECTIVENESS OF D-STAT HAS NOT BEEN ESTABLISHED FOR USE TO CONTROL BLEEDING FOLLOWING ORGAN OR TISSUE BIOPSIES. USE OF D-STAT IN THIS SITUATION HAS BEEN REPORTED TO RESULT IN PAIN, SEIZURES, BILE RETENTION, TISSUE NECROSIS, VASCULAR OCCLUSION AND DEATH.?
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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 |