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)

Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set

K-Number: K233988 · 2024-01-17

ApplicantCerenovus, Inc.
Decision Date2024-01-17
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Cerenovus, Inc.. It received FDA 510(k) clearance on 2024-01-17 under 510(k) number K233988. 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 Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set?

Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2024-01-17. The listed applicant is Cerenovus, Inc.. The 510(k) number is K233988.

When did Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set receive FDA 510(k) clearance?

Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set received FDA 510(k) clearance on 2024-01-17, under 510(k) number K233988.

Who is the listed applicant for Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set?

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

What is the FDA product code for Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set?

The FDA product code for Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set 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 TubingCOMPLETEDNCT06615713CLinical Evaluation of Aspiration for Removal ANd ClearancE of StonesCOMPLETEDNCT06851481The Ladera Suture-Mediated Large Bore Closure StudyCOMPLETEDNCT07216170REVascularization In Large VEssel Occlusion for Acute Ischemic StrokeNOT_YET_RECRUITINGNCT07541235The Ladera Suture-Mediated Large Bore Closure Pivotal StudyNOT_YET_RECRUITING

Other records listing Cerenovus, 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.

K262419MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MFK262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setPMA P990040tissue adhesive for use in embolization of brain arteriovenous malformationsK251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetK241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterK241221CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set

View all 11 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.

K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited

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.

↑