DESERET ARTERIAL CATHETER— 510(k) K851327
Substantially EquivalentParke-Davis Co.
FDA 510(k) clearance K851327 for DESERET ARTERIAL CATHETER, Substantially Equivalent on 1985-06-14. Applicant: Parke-Davis Co..
Clearance details
- Applicant
- Parke-Davis Co.
- Product code
- Code FOZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, MI, US
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.