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)

MANDREL GUIDEWIRES OR M-WIRE

K-Number: K080508 · 2008-03-21

ApplicantLake Region Medical
Decision Date2008-03-21
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MANDREL GUIDEWIRES OR M-WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Medical. It received FDA 510(k) clearance on 2008-03-21 under 510(k) number K080508. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANDREL GUIDEWIRES OR M-WIRE?

MANDREL GUIDEWIRES OR M-WIRE is a medical device that received FDA 510(k) clearance on 2008-03-21. The listed applicant is Lake Region Medical. The 510(k) number is K080508.

When did MANDREL GUIDEWIRES OR M-WIRE receive FDA 510(k) clearance?

MANDREL GUIDEWIRES OR M-WIRE received FDA 510(k) clearance on 2008-03-21, under 510(k) number K080508.

Who is the listed applicant for MANDREL GUIDEWIRES OR M-WIRE?

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

What is the FDA product code for MANDREL GUIDEWIRES OR M-WIRE?

The FDA product code for MANDREL GUIDEWIRES OR M-WIRE is OCY.

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 Lake Region Medical 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.

K253746Enroute 0.014'' Transcarotid GuidewireK242824PTFE GuidewireK221575Pre-Formed BlueK211741Pre-Formed Extra Support GuidewireK160643ENROUTE 0.014 GuidewireK124052OSTAVI HYDROPHILIC GUIDEWIRE

View all 9 devices →

Related Devices (Code: OCY)

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.

K153264EasyPass GuidewireMedi-Globe CorporationK131072ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILICColoplast A/SK124052OSTAVI HYDROPHILIC GUIDEWIRELake Region MedicalK123438XENX STONE MANAGEMENT DEVICEXenolith MedicalK123439NEO ERCP GUIDEWIRENeometrics, Inc.K122816AXCESS SOFT TIP WIRE GUIDEWilson-Cook 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.

↑