MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER— 510(k) K955839
Substantially EquivalentBaxter Edwards
FDA 510(k) clearance K955839 for MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER, Substantially Equivalent on 1996-03-25. Applicant: Baxter Edwards. Device class: 2.
Clearance details
- Applicant
- Baxter Edwards
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code FOZ
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 FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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 K955839
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955839.
Data sourced from openFDA. This site is unofficial and independent of the FDA.