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FDA 510(k)

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set

K-Number: K193380 · 2020-07-20

ApplicantCodman & Shurtleff, Inc.
Decision Date2020-07-20
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set is a medical device manufactured by Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2020-07-20 under approval number K193380. 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 2020-07-20. It is manufactured by Codman & Shurtleff, Inc.. The 510(k) number is K193380.

When was CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set approved by the FDA?

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set received FDA 510(k) clearance on 2020-07-20, under approval number K193380.

What company makes CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set?

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set is manufactured by Codman & Shurtleff, Inc..

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

NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT07216170 REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke NOT_YET_RECRUITING NCT07356284 Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07571954 Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy NOT_YET_RECRUITING NCT07577232 Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess RECRUITING

Other Devices by Codman & Shurtleff, Inc.

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Related Devices (Code: NRY)

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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.

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