CURITY THORACENTESIS TRAY— 510(k) K964519
Substantially EquivalentKendall Healthcare Products Co. Div.Of Tyco Health
FDA 510(k) clearance K964519 for CURITY THORACENTESIS TRAY, Substantially Equivalent on 1996-12-20. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health.
Clearance details
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
- Product code
- Code GCX
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Adverse events under product code GCX
product code GCX- Death
- 9
- Malfunction
- 592
- Other
- 2
- Total
- 603
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.