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FDA 510(k)

Liver Access and Biopsy Sets

K-Number: K171853 · 2017-08-24

ApplicantCook Incorporated
Decision Date2017-08-24
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Liver Access and Biopsy Sets is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-08-24 under approval number K171853. 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 Liver Access and Biopsy Sets?

Liver Access and Biopsy Sets is a medical device that received FDA 510(k) clearance on 2017-08-24. It is manufactured by Cook Incorporated. The 510(k) number is K171853.

When was Liver Access and Biopsy Sets approved by the FDA?

Liver Access and Biopsy Sets received FDA 510(k) clearance on 2017-08-24, under approval number K171853.

What company makes Liver Access and Biopsy Sets?

Liver Access and Biopsy Sets is manufactured by Cook Incorporated.

What is the FDA product code for Liver Access and Biopsy Sets?

The FDA product code for Liver Access and Biopsy Sets is DYB.

Related Clinical Trials

NCT07234188 POM vs HFNC for Hypoxemia Prevention in Children COMPLETED NCT05574361 Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA) ACTIVE_NOT_RECRUITING NCT05286814 PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma RECRUITING NCT00102544 Use of Tracking Devices to Locate Abnormalities During Invasive Procedures ENROLLING_BY_INVITATION NCT07530419 Samsung S-Viscosity vs Canon Dispersion Slope in Steatotic Liver Disease (SAVID-SLD) NOT_YET_RECRUITING NCT06877026 FibroScan-Reproducibility and Repeatability Study COMPLETED

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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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