510(k) K122612
- Device
- HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
- Applicant
- MAQUET CARDIOVASCULAR, LLC
- 510(k) number
- K122612
- Product code
- MAL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-09-10
- Date received
- 2012-08-27
- Regulation
- 870.3450
- Classification name
- Graft, Vascular, Synthetic/biologic Composite
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARYLOU INSINGA
- Address
- 45 Barbour Pond Dr. Wayne NJ US 07470 07470
FDA Registration Numbers#
- 9612515
- 1640201
- 1220948
- 2246552
- 3010162973
- 3010407203
Source Documents#
Other 510(k) Records For Product Code MAL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K103080 | ALBOGRAFT VASCULAR PROSTHESIS | LeMaitre Vascular, Inc. | 2011-01-19 |
| K093231 | ALBOGRAFT VASCULAR PROSTHESIS | LeMaitre Vascular, Inc. | 2010-01-14 |
| K052302 | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION | Boston Scientific Corp | 2005-09-12 |
| K021213 | MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS | Boston Scientific Corp | 2002-04-19 |
| K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-01 |
Legacy Summary#
summary
FDA Review#
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