BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS— 510(k) K944858
Substantially Equivalent - Subject to Tracking Reg.Baxter Edwards
FDA 510(k) clearance K944858 for BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS, Substantially Equivalent - Subject to Tracking Reg. on 1995-01-05. Applicant: Baxter Edwards. Device class: 2.
Clearance details
- Applicant
- Baxter Edwards
- Product code
- Code DSY
- Device class
- Class 2
- Regulation
- 21 CFR 870.3450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code DSY
view allMore clearances from Baxter Edwards
view all- K993816 — BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD
- K981909 — BAXTER HEMOSTASIS VALVE INTRODUCERS
- K980487 — CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM
- K965137 — FOGARTY VALVULOTOME MODEL 700091
- K964021 — INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.