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

FDA 510(k)

Penumbra System (Modified 110 Aspiration Tubing)

K-Number: K182522 · 2018-10-12

ApplicantPenumbra, Inc.
Decision Date2018-10-12
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Penumbra System (Modified 110 Aspiration Tubing) is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2018-10-12 under approval number K182522. 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 (Modified 110 Aspiration Tubing)?

Penumbra System (Modified 110 Aspiration Tubing) is a medical device that received FDA 510(k) clearance on 2018-10-12. It is manufactured by Penumbra, Inc.. The 510(k) number is K182522.

When was Penumbra System (Modified 110 Aspiration Tubing) approved by the FDA?

Penumbra System (Modified 110 Aspiration Tubing) received FDA 510(k) clearance on 2018-10-12, under approval number K182522.

What company makes Penumbra System (Modified 110 Aspiration Tubing)?

Penumbra System (Modified 110 Aspiration Tubing) is manufactured by Penumbra, Inc..

What is the FDA product code for Penumbra System (Modified 110 Aspiration Tubing)?

The FDA product code for Penumbra System (Modified 110 Aspiration Tubing) is NRY.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07611968 Prospective Evaluation of Physician Modified Endografts for Aortic Disease NOT_YET_RECRUITING NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING

Other Devices by Penumbra, Inc.

K161506Penumbra Aspiration System K161640Penumbra System ACE 68 Reperfusion Catheter K161523INDIGO Aspiration System K161064Penumbra System ACE 68 Reperfusion Catheter K160449Penumbra System, Penumbra Pump MAX K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

View all 59 devices →

Related Devices (Code: NRY)

K161879Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc. K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

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.

↑