AVF SET FOR SINGLE NEEDLE HEMODIALYSIS— 510(k) K772362
Substantially EquivalentTerumo America, Inc.
FDA 510(k) clearance K772362 for AVF SET FOR SINGLE NEEDLE HEMODIALYSIS, Substantially Equivalent on 1978-03-17. Applicant: Terumo America, Inc.. Device class: 2.
Clearance details
- Applicant
- Terumo America, Inc.
- Product code
- Code FIE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- 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 FIE
product code FIE- Death
- 2
- Total
- 2
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.