Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Penumbra System (Thunderbolt Aspiration Tubing)

K-Number: K250690 · 2026-06-10

ApplicantPenumbra, Inc.
Decision Date2026-06-10
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Penumbra System (Thunderbolt Aspiration Tubing) is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K250690. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Penumbra System (Thunderbolt Aspiration Tubing)?

Penumbra System (Thunderbolt Aspiration Tubing) is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is Penumbra, Inc.. The 510(k) number is K250690.

When did Penumbra System (Thunderbolt Aspiration Tubing) receive FDA 510(k) clearance?

Penumbra System (Thunderbolt Aspiration Tubing) received FDA 510(k) clearance on 2026-06-10, under 510(k) number K250690.

Who is the listed applicant for Penumbra System (Thunderbolt Aspiration Tubing)?

The FDA 510(k) record lists Penumbra, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Penumbra System (Thunderbolt Aspiration Tubing)?

The FDA product code for Penumbra System (Thunderbolt Aspiration Tubing) is NRY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05437055THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration TubingCOMPLETEDNCT04798261Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration SystemRECRUITINGNCT05003843BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein ThrombosisACTIVE_NOT_RECRUITINGNCT05684796Comparison of Two Pulmonary Embolism TreatmentsCOMPLETEDNCT06747117A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)RECRUITINGNCT07107022Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).RECRUITING

Other records listing Penumbra, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260599INDIGO® Aspiration System – INDIGO LinkK251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKK252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration TubingK250079Ruby XL SystemK242104Penumbra System (Reperfusion Catheter RED 72)K242033Access25™ Delivery Microcatheter

View all 60 devices →

Related Devices (Code: NRY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech LimitedK254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.K253590Millipede SystemPerfuze, Ltd.K253062Tigertriever 25 Revascularization DeviceRapid Medical , Ltd.K251357Esperance pHLO Aspiration SystemPhenox, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑