HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION— 510(k) K052302
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K052302 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION, Substantially Equivalent on 2005-09-12. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code MAL
- Device class
- Class 2
- Regulation
- 21 CFR 870.3450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Maple Grove, MN, US
Recent devices under product code MAL
view all- K122612 — HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
- K103080 — ALBOGRAFT VASCULAR PROSTHESIS
- K093231 — ALBOGRAFT VASCULAR PROSTHESIS
- K021213 — MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
- K954848 — HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
More clearances from Boston Scientific Corp
view all- K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170) +2 more
- K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312)
- K152853 — WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
- K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System
- K150303 — XXL Vascular Balloon Dilatation Catheter
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 →
Recalls naming K052302
K-number listed on FDA's recall record- Z-1862-2020 — HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
- Z-1863-2020 — HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052302.
Data sourced from openFDA. This site is unofficial and independent of the FDA.