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)

CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE

K-Number: K120298 · 2012-05-08

ApplicantSt. Jude Medical, Cardiac Rhythm Management Divisi
Decision Date2012-05-08
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Cardiac Rhythm Management Divisi. It received FDA 510(k) clearance on 2012-05-08 under 510(k) number K120298. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE?

CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is St. Jude Medical, Cardiac Rhythm Management Divisi. The 510(k) number is K120298.

When did CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE receive FDA 510(k) clearance?

CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE received FDA 510(k) clearance on 2012-05-08, under 510(k) number K120298.

Who is the listed applicant for CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE?

The FDA 510(k) record lists St. Jude Medical, Cardiac Rhythm Management Divisi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE?

The FDA product code for CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE is DQX.

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 St. Jude Medical, Cardiac Rhythm Management Divisi 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.

K122090SJM CONFIRM IMPLANTABLE CARDIAC MONITORK120296CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETERK111943AGILLS PF DELIVERY SYSTEMK103250CPS DIRECT SL II SLITTABLE OUTER CATHETERK093858PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053AK092075CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005

View all 10 devices →

Related Devices (Code: DQX)

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., 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.

↑