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)

450CM GUIDE WIRE FOR G.I. USE

K-Number: K910722 · 1991-03-21

ApplicantTerumo Corp.
Decision Date1991-03-21
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

450CM GUIDE WIRE FOR G.I. USE is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corp.. It received FDA 510(k) clearance on 1991-03-21 under 510(k) number K910722. 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 450CM GUIDE WIRE FOR G.I. USE?

450CM GUIDE WIRE FOR G.I. USE is a medical device that received FDA 510(k) clearance on 1991-03-21. The listed applicant is Terumo Corp.. The 510(k) number is K910722.

When did 450CM GUIDE WIRE FOR G.I. USE receive FDA 510(k) clearance?

450CM GUIDE WIRE FOR G.I. USE received FDA 510(k) clearance on 1991-03-21, under 510(k) number K910722.

Who is the listed applicant for 450CM GUIDE WIRE FOR G.I. USE?

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

What is the FDA product code for 450CM GUIDE WIRE FOR G.I. USE?

The FDA product code for 450CM GUIDE WIRE FOR G.I. USE 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 Terumo Corp. 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.

K100282TERUMO SURSHIELD- PUR SAFETY I.V. CATHETERK092372HEARTRAIL III GUIDING CATHETERK091417SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527AK090973TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)K073474CAPIOX CIRCUIT CONNECTORSK071572CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

View all 21 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.

↑