MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR— 510(k) K000087
Substantially EquivalentThe Kendal Co.
FDA 510(k) clearance K000087 for MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR, Substantially Equivalent on 2000-03-17. Applicant: The Kendal Co.. Device class: 2.
Clearance details
- Applicant
- The Kendal Co.
- 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
- Mansfield, MA, US
Recent devices under product code FOZ
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- K991758 — MONOJECT INSULIN SYRINGE
- K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
- K951488 — KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
- K942664 — KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.