THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101— 510(k) K831424
Substantially EquivalentExtracorporeal Medical Specialities, Inc.
FDA 510(k) clearance K831424 for THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101, Substantially Equivalent on 1983-10-14. Applicant: Extracorporeal Medical Specialities, Inc..
Clearance details
- Applicant
- Extracorporeal Medical Specialities, Inc.
- Product code
- Code FJK
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code FJK
product code FJK- Death
- 52
- Malfunction
- 3,430
- Total
- 3,482
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.