FDA 510(k)

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables

K-Number: K152670 · 2016-01-22

Decision Date2016-01-22

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2016-01-22 under approval number K152670. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables?

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables is a medical device that received FDA 510(k) clearance on 2016-01-22. It is manufactured by Medos International SARL. The 510(k) number is K152670.

When was DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables approved by the FDA?

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables received FDA 510(k) clearance on 2016-01-22, under approval number K152670.

What company makes DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables?

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables is manufactured by Medos International SARL.

What is the FDA product code for DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables?

The FDA product code for DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables is GWM.

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Related PubMed Literature

PMID: 28216355 Innovative postmarket device evaluation using a quality registry to monitor thoracic endovascular aortic repair in the treatment of aortic dissection. Journal of vascular surgery (2017)

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Related Devices (Code: GWM)

K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc. K153347Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter KitCodman & Shurtleff, Inc. K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitCodman & Shurtleff, Inc. K171666MPR2 logO DATALOGGERRaumedic AG K162108Pressio 2 ICP Monitoring SystemSophysa SA K172209AURA ICP MONITORING SYSTEMBranchpoint Technologies, Inc.

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.