Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12— 510(k) K192981
Substantially EquivalentPenumbra, Inc.
FDA 510(k) clearance K192981 for Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12, Substantially Equivalent on 2020-05-28. Applicant: Penumbra, Inc.. Device class: 2.
Clearance details
- Applicant
- Penumbra, Inc.
- Product code
- Code QEW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
Recent devices under product code QEW
view allMore clearances from Penumbra, Inc.
view all- K250690 — Penumbra System (Thunderbolt Aspiration Tubing)
- K252612 — INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing
- K250079 — Ruby XL System
- K242104 — Penumbra System (Reperfusion Catheter RED 72)
- K242033 — Access25 Delivery Microcatheter
Adverse events under product code QEW
product code QEW- Death
- 126
- Injury
- 282
- Malfunction
- 820
- Total
- 1,228
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.