TERUMO AV FISTULA NEEDLE SET— 510(k) K891062
Substantially EquivalentTerumo Medical Corp.
FDA 510(k) clearance K891062 for TERUMO AV FISTULA NEEDLE SET, Substantially Equivalent on 1989-06-22. Applicant: Terumo Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Terumo Medical Corp.
- 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
- Elkton, MD, US
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More clearances from Terumo Medical Corp.
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.