PENUMBRA COIL SYSTEM/PENUMBRA COIL 400— 510(k) K120330
Substantially EquivalentPenumbra, Inc.
FDA 510(k) clearance K120330 for PENUMBRA COIL SYSTEM/PENUMBRA COIL 400, Substantially Equivalent on 2012-04-02. Applicant: Penumbra, Inc.. Device class: 2.
Clearance details
- Applicant
- Penumbra, Inc.
- Product code
- Code HCG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
Recent devices under product code HCG
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- K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
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- K250079 — Ruby XL System
Adverse events under product code HCG
product code HCG- Death
- 50
- Injury
- 801
- Malfunction
- 5,625
- Total
- 6,476
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.