Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IRRAflow CNS System

K-Number: K171880 · 2018-07-13

ApplicantIrras, Inc.
Decision Date2018-07-13
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

IRRAflow CNS System is the device name listed in this FDA 510(k) record. The listed applicant is Irras, Inc.. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K171880. 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 IRRAflow CNS System?

IRRAflow CNS System is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Irras, Inc.. The 510(k) number is K171880.

When did IRRAflow CNS System receive FDA 510(k) clearance?

IRRAflow CNS System received FDA 510(k) clearance on 2018-07-13, under 510(k) number K171880.

Who is the listed applicant for IRRAflow CNS System?

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

What is the FDA product code for IRRAflow CNS System?

The FDA product code for IRRAflow CNS System 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

View on FDA Database →

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

↑