Product code MAL— Cardiovascular
ALBOGRAFT VASCULAR PROSTHESIS
- Classification name
- Graft, Vascular, Synthetic/Biologic Composite
- Device class
- Class 2
- Regulation
- 21 CFR 870.3450
- Advisory panel
- Cardiovascular
- Total cleared
- 6
- First cleared
- Most recent
Market context for product code MAL
FDA has cleared devices under product code MAL between 1996 and 2012, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2012
- 2011
- 2010
- 2005
- 2002
- 1996
Top applicants under product code MAL
Adverse events under product code MAL
product code MAL- Death
- 4
- Total
- 4
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MAL
- K122612 — HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
- K103080 — ALBOGRAFT VASCULAR PROSTHESIS
- K093231 — ALBOGRAFT VASCULAR PROSTHESIS
- K052302 — HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
- K021213 — MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
- K954848 — HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
Data sourced from openFDA. This site is unofficial and independent of the FDA.