SHELLY PROTECTED AV FISTULA NEEDLE— 510(k) K992653
Substantially EquivalentDiasol, Inc.
FDA 510(k) clearance K992653 for SHELLY PROTECTED AV FISTULA NEEDLE, Substantially Equivalent on 1999-10-27. Applicant: Diasol, Inc.. Device class: 2.
Clearance details
- Applicant
- Diasol, 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
- North Hollywood, CA, US
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More clearances from Diasol, 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.