ARISTA AH ABSORBABLE HEMOSTAT
FDA premarket approval P050038/S007 · decided 2008-07-02
Approval details
- PMA number
- P050038
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ARISTA AH ABSORBABLE HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- Davol, Inc.
- Date received
- 2008-06-17
- Decision date
- 2008-07-02
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Warwick, RI
- Statement
- APPROVAL FOR THE ADDITION OF A NEW TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITASURE AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (EXCEPT NEUROLOGICAL AND OPHTHALMIC) AS AN ADJUNCTIVE HEMOSTATIC DEVICE TO ASSIST WHEN CONTROL OF CAPILLARY, VENOUS, AND ARTERIAL BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
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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 |