PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054— 510(k) K100769
Substantially EquivalentPenumbra, Inc.
FDA 510(k) clearance K100769 for PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054, Substantially Equivalent on 2010-05-21. Applicant: Penumbra, Inc.. Device class: 2.
Clearance details
- Applicant
- Penumbra, Inc.
- Product code
- Code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Alameda, CA, US
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Adverse events under product code NRY
product code NRY- Death
- 411
- Injury
- 1,712
- Malfunction
- 1,855
- Total
- 3,978
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.