VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
FDA premarket approval P990037/S024 · decided 2006-12-22
Approval details
- PMA number
- P990037
- Supplement
- S024
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vascular Solutions, Inc.
- Date received
- 2006-06-22
- Decision date
- 2006-12-22
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A NEW INDICATION FOR USE FOR THE D-STAT FLOWABLE HEMOSTAT. THE DEVICE IS INDICATED FOR USE IN HIGH-RISK ANTI-COAGULATED PATIENTS UNDERGOING IMPLANTATION OF A PULSE GENERATOR (E.G., PACEMAKER OR ICD) TO REDUCE THE FREQUENCY OF CLINICALLY RELEVANT HEMATOMA FORMATION IN THE PREPECTORAL POCKET. D-STAT FLOWABLE IS INDICATED FOR USE IN HIGH-RISK ANTI-COAGULATED PATIENTS UNDERGOING IMPLANTATION OF A PULSE GENERATOR (E.G., PACEMAKER OR ICD TO REDUCE THE FREQUENCY OF CLINICALLY RELEVANT HEMA
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 |