MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
FDA 510(k) clearance K021213 · decided 2002-04-19
Clearance details
- K-number
- K021213
- Device name
- MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2002-04-17
- Decision date
- 2002-04-19
- Days to decision
- 2 days
- Clearance type
- Special
- Product code
- MAL
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boston Scientific Corp
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX (K122612) | Maquet Cardiovascular, LLC | 2012-09-10 |
| ALBOGRAFT VASCULAR PROSTHESIS (K103080) | LeMaitre Vascular, Inc. | 2011-01-19 |
| ALBOGRAFT VASCULAR PROSTHESIS (K093231) | LeMaitre Vascular, Inc. | 2010-01-14 |
| HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION (K052302) | Boston Scientific Corp | 2005-09-12 |
| HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT (K954848) | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-01 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hemashield Platinum Woven and Knitted Double Velour Vascular Grafts. recall (Z-2063-2010) | Maquet Cardiovascular, LLC | 2010-07-22 |