GORE PROPATEN VASCULAR GRAFT— 510(k) K062161
Substantially EquivalentW. L. Gore & Associates, Inc.
FDA 510(k) clearance K062161 for GORE PROPATEN VASCULAR GRAFT, Substantially Equivalent on 2006-11-09. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.
Clearance details
- Applicant
- W. L. Gore & Associates, Inc.
- Product code
- Code DSY
- Device class
- Class 2
- Regulation
- 21 CFR 870.3450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Flagstaff, AZ, US
Recent devices under product code DSY
view allMore clearances from W. L. Gore & Associates, Inc.
view allAdverse events under product code DSY
product code DSY- Death
- 29
- Injury
- 694
- Total
- 723
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 K062161
K-number listed on FDA's recall record- Z-2292-2021 — Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
- Z-2293-2021 — Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062161.
Data sourced from openFDA. This site is unofficial and independent of the FDA.