CLIRANS TE15 HOLLOW FIBER DIALYZER— 510(k) K801193
Substantially EquivalentTerumo America, Inc.
FDA 510(k) clearance K801193 for CLIRANS TE15 HOLLOW FIBER DIALYZER, Substantially Equivalent on 1980-08-12. Applicant: Terumo America, Inc.. Device class: 2.
Clearance details
- Applicant
- Terumo America, Inc.
- Product code
- Code KDJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Terumo America, Inc.
view allAdverse events under product code KDJ
product code KDJ- Death
- 298
- Injury
- 9,221
- Malfunction
- 8,438
- Other
- 1
- Total
- 17,958
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.