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)

Extra Large Check-Flo Introducer

K-Number: K203670 · 2021-02-16

ApplicantCook Incorporated
Decision Date2021-02-16
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Extra Large Check-Flo Introducer is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2021-02-16 under approval number K203670. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Extra Large Check-Flo Introducer?

Extra Large Check-Flo Introducer is a medical device that received FDA 510(k) clearance on 2021-02-16. It is manufactured by Cook Incorporated. The 510(k) number is K203670.

When was Extra Large Check-Flo Introducer approved by the FDA?

Extra Large Check-Flo Introducer received FDA 510(k) clearance on 2021-02-16, under approval number K203670.

What company makes Extra Large Check-Flo Introducer?

Extra Large Check-Flo Introducer is manufactured by Cook Incorporated.

What is the FDA product code for Extra Large Check-Flo Introducer?

The FDA product code for Extra Large Check-Flo Introducer is DYB.

Related Clinical Trials

NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING NCT05743673 SHAPE Test for Preoperative Risk Stratification RECRUITING NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING NCT07541235 The Ladera Suture-Mediated Large Bore Closure Pivotal Study NOT_YET_RECRUITING NCT06355713 Improvement of Symptoms After Removal of the Essure® Contraceptive Implant RECRUITING

Other Devices by Cook Incorporated

K160884CXI Support Catheter K161822Torcon NB Advantage Catheters K161496Turbo-Flo PICC Sets K160217uVue HSG/SHG Catheter K161002Aprima Smartesis Centesis Pump K153761Emergency Transtracheal Airway Catheter

View all 147 devices →

Related Devices (Code: DYB)

K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC K162097InTRAkitMedtronic Vascular K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc. K153771TXM Guiding SheathTexasmedical Technologies, Inc. K162184Edwards eSheath Introducer SetEdward Lifesciences K153494HQS Introducer (Model 2064-HQS)Alseal

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.

↑