Penumbra System (Thunderbolt Aspiration Tubing)— 510(k) K250690
Substantially EquivalentPenumbra, Inc.
FDA 510(k) clearance K250690 for Penumbra System (Thunderbolt Aspiration Tubing), Substantially Equivalent on 2026-06-10. Applicant: Penumbra, Inc.. Device class: 2.
Summary
Penumbra's clearance names the Penumbra System, with Thunderbolt Aspiration Tubing given in parentheses. It's filed under NRY, thrombus retriever catheters, and the record doesn't list other components.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Traditional 510(k); the record lists Cardiovascular as the classification panel.
Penumbra filed from Alameda, California. The decision came 460 calendar days after FDA received it (March 7, 2025 to June 10, 2026).
Clearance details
- Applicant
- Penumbra, Inc.
- Product code
- Product code NRY
- 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 NRY
view all- K262021 — Toro 71 Aspiration Catheter; Toro Aspiration Tubing
- K263266 — Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set
- K261089 — Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
- K260617 — Tigertriever 13 Ultra Revascularization Device
- K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set
More clearances from Penumbra, Inc.
view all- K262904 — INDIGO® Aspiration System
- 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
- K250079 — Ruby XL System
Adverse events under product code NRY
product code NRY- Death
- 411
- Injury
- 1,712
- Malfunction
- 1,855
- Total
- 3,978
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 →
Recalls naming K250690
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K250690.
Data sourced from openFDA. This site is unofficial and independent of the FDA.