FDA 510(k)

4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[

K-Number: K952638 · 1995-07-28

Decision Date1995-07-28

Product CodeLYK

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Edwards. It received FDA 510(k) clearance on 1995-07-28 under 510(k) number K952638. 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 CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[?

4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ is a medical device that received FDA 510(k) clearance on 1995-07-28. The listed applicant is Baxter Edwards. The 510(k) number is K952638.

When did 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ receive FDA 510(k) clearance?

4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ received FDA 510(k) clearance on 1995-07-28, under 510(k) number K952638.

Who is the listed applicant for 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[?

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 CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[?

The FDA product code for 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Baxter Edwards as applicant

K993816BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD K981909BAXTER HEMOSTASIS VALVE INTRODUCERS K980487CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM K965137FOGARTY VALVULOTOME MODEL 700091 K964021INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)K955839MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER

View all 11 devices →

Related Devices (Code: LYK)

K253842Vena MicroAngioscope™ SystemVena Medical Holdings Corp K251767Vena MicroAngioscope™ SystemVena Medical Holdings Corp K062340CARDIOOPTICS 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.