POSITIVE PLACEMENT ANETHESIA KIT— 510(k) K781469
Substantially EquivalentArrow Intl., Inc.
FDA 510(k) clearance K781469 for POSITIVE PLACEMENT ANETHESIA KIT, Substantially Equivalent on 1979-01-26. Applicant: Arrow Intl., Inc..
Clearance details
- Applicant
- Arrow Intl., Inc.
- Product code
- Code CAZ
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Adverse events under product code CAZ
product code CAZ- Injury
- 145
- Malfunction
- 942
- Other
- 1
- Total
- 1,088
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.