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)

4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45

K-Number: K926433 · 1993-03-23

ApplicantBaxter Edwards
Decision Date1993-03-23
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Edwards. It received FDA 510(k) clearance on 1993-03-23 under 510(k) number K926433. The device is classified under product code LYK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45?

4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 is a medical device that received FDA 510(k) clearance on 1993-03-23. The listed applicant is Baxter Edwards. The 510(k) number is K926433.

When did 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 receive FDA 510(k) clearance?

4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 received FDA 510(k) clearance on 1993-03-23, under 510(k) number K926433.

Who is the listed applicant for 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45?

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

What is the FDA product code for 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45?

The FDA product code for 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 is LYK.

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 Baxter Edwards 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.

K993816BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FDK981909BAXTER HEMOSTASIS VALVE INTRODUCERSK980487CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSMK965137FOGARTY VALVULOTOME MODEL 700091K964021INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)K955839MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER

View all 11 devices →

Related Devices (Code: LYK)

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.

K253842Vena MicroAngioscope™ SystemVena Medical Holdings CorpK251767Vena MicroAngioscope™ SystemVena Medical Holdings CorpK062340CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEMCardio-Optics, Inc.K050808CORONARY SINUS ACCESS KIT, MODEL KCS8F-01Cardio-Optics, Inc.K011793KSEA FIBERSCOPEKARL STORZ Endoscopy-America, Inc.K012724SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273Smith & Nephew, 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.

↑