FDA product code MAL: Graft, Vascular, Synthetic/Biologic Composite
MAL is the FDA product code for graft, vascular, synthetic/biologic composite. It is a Class II device, regulated under 21 CFR 870.3450 and reviewed by the Cardiovascular panel. FDA has cleared 6 510(k) submissions under MAL, from 4 different applicants. The average 510(k) review took 53 days (median 56). 2 PMA applications cite this product code. FDA has posted 49 recalls for MAL devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Graft, Vascular, Synthetic/Biologic Composite |
| Device class | Class II |
| Regulation | 21 CFR 870.3450 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every MAL clearance
Top MAL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| LeMaitre Vascular, Inc. | 2 | 2011-01-19 |
| Boston Scientific Corp | 2 | 2005-09-12 |
| Maquet Cardiovascular, LLC | 1 | 2012-09-10 |
| Meadox Medicals, Div. Boston Scientific Corp. | 1 | 1996-02-01 |
Most recent MAL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122612 | Maquet Cardiovascular, LLC | HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX | 2012-09-10 | 14 |
| K103080 | LeMaitre Vascular, Inc. | ALBOGRAFT VASCULAR PROSTHESIS | 2011-01-19 | 92 |
| K093231 | LeMaitre Vascular, Inc. | ALBOGRAFT VASCULAR PROSTHESIS | 2010-01-14 | 92 |
| K052302 | Boston Scientific Corp | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION | 2005-09-12 | 19 |
| K021213 | Boston Scientific Corp | MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS | 2002-04-19 | 2 |
Recalls for MAL devices
49 product recalls in 7 recall events; 2 initiated in the last five years and 0 still open. Most recent: 2022-01-14.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 24 |
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code MAL?
MAL is the FDA product code for graft, vascular, synthetic/biologic composite. It is a Class II device, regulated under 21 CFR 870.3450 and reviewed by the Cardiovascular panel.
What device class is MAL?
Class II, regulation 21 CFR 870.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code MAL?
Across 6 cleared submissions the average was 53 days from receipt to decision (median 56).
Which companies have the most MAL clearances?
LeMaitre Vascular, Inc. (2); Boston Scientific Corp (2); Maquet Cardiovascular, LLC (1); Meadox Medicals, Div. Boston Scientific Corp. (1).
Have MAL devices been recalled?
Yes: 49 product recalls across 7 recall events; the most recent began 2022-01-14.
Next steps
- Run an FDA pathway report with predicate devices for product code MAL
- Run a recall and safety report across every MAL manufacturer
- Watch product code MAL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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