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)

EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE

K-Number: K033542 · 2003-12-05

ApplicantGalt Medical Corp.
Decision Date2003-12-05
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Galt Medical Corp.. It received FDA 510(k) clearance on 2003-12-05 under 510(k) number K033542. 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 EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE?

EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2003-12-05. The listed applicant is Galt Medical Corp.. The 510(k) number is K033542.

When did EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE receive FDA 510(k) clearance?

EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE received FDA 510(k) clearance on 2003-12-05, under 510(k) number K033542.

Who is the listed applicant for EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE?

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

What is the FDA product code for EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE?

The FDA product code for EASY PASS HYDROPHILIC COATED VASCULAR 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 Galt Medical 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.

K192195Sterile DilatorK182660GaltTWSK173287Elite HV RadialK172487Coaxial Dilator Set (Micro-Introducer)K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerK123430MICROSLIDER TEARAWAY INTRODUCER SET

View all 12 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.

↑