INDIGO Aspiration System— 510(k) K163618
UnknownPenumbra, Inc.
FDA 510(k) clearance K163618 for INDIGO Aspiration System, Unknown on 2017-05-24. Applicant: Penumbra, Inc.. Device class: 2.
Clearance details
- Applicant
- Penumbra, Inc.
- Product code
- Code QEX
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Alameda, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.