KENDALL DUAL LUMEN CATHETER— 510(k) K963446
Substantially EquivalentKendall Healthcare Products Co. Div.Of Tyco Health
FDA 510(k) clearance K963446 for KENDALL DUAL LUMEN CATHETER, Substantially Equivalent on 1997-03-18. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health.
Clearance details
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
- Product code
- Code MPB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Adverse events under product code MPB
product code MPB- Death
- 18
- Malfunction
- 1,042
- Total
- 1,060
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.