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FDA 510(k)

SureFlo EVD Catheter

K-Number: K170599 · 2017-08-31

ApplicantArkis Biosciences, Inc.
Decision Date2017-08-31
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SureFlo EVD Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Arkis Biosciences, Inc.. It received FDA 510(k) clearance on 2017-08-31 under 510(k) number K170599. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SureFlo EVD Catheter?

SureFlo EVD Catheter is a medical device that received FDA 510(k) clearance on 2017-08-31. The listed applicant is Arkis Biosciences, Inc.. The 510(k) number is K170599.

When did SureFlo EVD Catheter receive FDA 510(k) clearance?

SureFlo EVD Catheter received FDA 510(k) clearance on 2017-08-31, under 510(k) number K170599.

Who is the listed applicant for SureFlo EVD Catheter?

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

What is the FDA product code for SureFlo EVD Catheter?

The FDA product code for SureFlo EVD Catheter is JXG.

Related Devices (Code: JXG)

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.

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production CorporationK251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)SophysaK252514EVAC-MRIPhasor Health, LLCK243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production CorporationK243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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