ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER— 510(k) K980919
Substantially EquivalentFortune Medical Instrument Corp.
FDA 510(k) clearance K980919 for ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER, Substantially Equivalent on 1998-03-31. Applicant: Fortune Medical Instrument Corp.. Device class: 2.
Clearance details
- Applicant
- Fortune Medical Instrument Corp.
- Product code
- Code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code EZL
view allMore clearances from Fortune Medical Instrument Corp.
view all- K022112 — FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
- K021193 — FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
- K021142 — ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
- K014002 — ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
- K980917 — ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
Adverse events under product code EZL
product code EZL- Death
- 6
- Injury
- 796
- Malfunction
- 4,989
- Other
- 1
- Total
- 5,792
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.