Ruby XL System— 510(k) K250079
Substantially EquivalentPenumbra, Inc.
FDA 510(k) clearance K250079 for Ruby XL System, Substantially Equivalent on 2025-03-14. Applicant: Penumbra, Inc.. Device class: 2.
Clearance details
- Applicant
- Penumbra, Inc.
- Product code
- Code KRD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
Recent devices under product code KRD
view allMore clearances from Penumbra, Inc.
view all- K250690 — Penumbra System (Thunderbolt Aspiration Tubing)
- K260599 — INDIGO® Aspiration System INDIGO Link
- K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
- K252612 — INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing
- K242104 — Penumbra System (Reperfusion Catheter RED 72)
Adverse events under product code KRD
product code KRD- Death
- 119
- Injury
- 1,869
- Malfunction
- 7,015
- Other
- 1
- Total
- 9,004
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.