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)

CHEMOLOCK, CHEMOLOCK PORT

K-Number: K131549 · 2013-07-26

ApplicantIcu Medical, Inc.
Decision Date2013-07-26
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHEMOLOCK, CHEMOLOCK PORT is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2013-07-26 under 510(k) number K131549. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMOLOCK, CHEMOLOCK PORT?

CHEMOLOCK, CHEMOLOCK PORT is a medical device that received FDA 510(k) clearance on 2013-07-26. The listed applicant is Icu Medical, Inc.. The 510(k) number is K131549.

When did CHEMOLOCK, CHEMOLOCK PORT receive FDA 510(k) clearance?

CHEMOLOCK, CHEMOLOCK PORT received FDA 510(k) clearance on 2013-07-26, under 510(k) number K131549.

Who is the listed applicant for CHEMOLOCK, CHEMOLOCK PORT?

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

What is the FDA product code for CHEMOLOCK, CHEMOLOCK PORT?

The FDA product code for CHEMOLOCK, CHEMOLOCK PORT is ONB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Icu Medical, Inc. as applicant

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.

K252130LifeShield Infusion Safety Software SuiteK252006OTTO™ Disinfecting CapK251980ClaveQS™ BagK250616Clave™ Neutral-Displacement Needlefree ConnectorsK242115Plum Duo™ Precision IV PumpK242114Plum Solo™ Precision IV Pump

View all 65 devices →

Related Devices (Code: ONB)

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.

K251722ProSeal™ Transfer Injector (421120, 421130, 421140)Epic Medical Pte. , Ltd.K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare , Ltd.K250059BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)Becton, Dickinson and CompanyK251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare , Ltd.K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte. , Ltd.K243976ZeroClear™ Bag Access (423100)Epic Medical Pte. , Ltd.

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.

↑