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FDA 510(k)

Silicone Peripherally Inserted Central Venous Catheter Set/Tray

K-Number: K171994 · 2018-02-22

ApplicantCook Incorporated
Decision Date2018-02-22
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Silicone Peripherally Inserted Central Venous Catheter Set/Tray is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K171994. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Silicone Peripherally Inserted Central Venous Catheter Set/Tray?

Silicone Peripherally Inserted Central Venous Catheter Set/Tray is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Cook Incorporated. The 510(k) number is K171994.

When did Silicone Peripherally Inserted Central Venous Catheter Set/Tray receive FDA 510(k) clearance?

Silicone Peripherally Inserted Central Venous Catheter Set/Tray received FDA 510(k) clearance on 2018-02-22, under 510(k) number K171994.

Who is the listed applicant for Silicone Peripherally Inserted Central Venous Catheter Set/Tray?

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

What is the FDA product code for Silicone Peripherally Inserted Central Venous Catheter Set/Tray?

The FDA product code for Silicone Peripherally Inserted Central Venous Catheter Set/Tray is LJS.

Related Clinical Trials

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Related Devices (Code: LJS)

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.

K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum VascularK252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.

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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