Arista AH Absorbable Hemostatic Particles
FDA premarket approval P050038/S035 · decided 2020-04-29
Approval details
- PMA number
- P050038
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Arista AH Absorbable Hemostatic Particles
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- Davol, Inc.
- Date received
- 2020-02-24
- Decision date
- 2020-04-29
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Warwick, RI
- Statement
- Approval for a change to the instructions for use on the cardiotomy filter size range to include a 20-40 micron size range for autologous blood salvage systems compatible with the device.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Bard® Mesh; Bard® Mesh Pre-Shaped (K251557) | Davol, Inc. | 2025-06-12 |
| Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (K250098) | Davol, Inc. | 2025-04-09 |
| AQUASENS FLUID MONITORING SYSTEM (K031213) | Davol, Inc. | 2003-04-30 |
| DAVOL ARTHROVENT OUTFLOW TUBING (K030307) | Davol, Inc. | 2003-02-13 |
| COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 (K003323) | Davol, Inc. | 2001-01-22 |
| DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 (K003790) | Davol, Inc. | 2000-12-22 |
| DAVOL ATS (K931899) | Davol, Inc. | 1994-11-15 |
| DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE (K941334) | Davol, Inc. | 1994-06-14 |