JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET— 510(k) K051814
Substantially EquivalentJms North America Corp.
FDA 510(k) clearance K051814 for JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET, Substantially Equivalent on 2005-08-04. Applicant: Jms North America Corp.. Device class: 2.
Clearance details
- Applicant
- Jms North America 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
- Special
- Location
- Hayward, CA, US
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More clearances from Jms North America 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.