DIANEAL SOLUTION EXCHANGE DEVICE #5C4193— 510(k) K822361
Substantially EquivalentTravenol Laboratories, S.A.
FDA 510(k) clearance K822361 for DIANEAL SOLUTION EXCHANGE DEVICE #5C4193, Substantially Equivalent on 1982-08-16. Applicant: Travenol Laboratories, S.A..
Clearance details
- Applicant
- Travenol Laboratories, S.A.
- Product code
- Code FKX
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code FKX
product code FKX- Death
- 501
- Injury
- 6,720
- Malfunction
- 18,508
- Other
- 1
- Total
- 25,730
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.