BENCHMARK BMX81 Access System— 510(k) K221822
Substantially EquivalentPenumbra, Inc.
FDA 510(k) clearance K221822 for BENCHMARK BMX81 Access System, Substantially Equivalent on 2022-11-04. Applicant: Penumbra, Inc.. Device class: 2.
Clearance details
- Applicant
- Penumbra, Inc.
- Product code
- Code QJP
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
Recent devices under product code QJP
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Adverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
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.