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510(k) K875108

Device
ACS CORONARY ANGIOSCOPIC CATHETER
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
510(k) number
K875108
Product code
LYK  
Decision
Substantially Equivalent (SESE)
Decision date
1988-09-27
Date received
1987-12-14
Regulation
876.1500
Classification name
Angioscope
Medical specialty
Gastroenterology/Urology
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL C KOLBER
Address
1395 Charleston Rd. Mountain View CA US 94043 94043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LYK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253842Vena MicroAngioscope™ SystemVena Medical Holdings Corp2026-01-28
K251767Vena MicroAngioscope™ SystemVena Medical Holdings Corp2025-10-01
K062340CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEMCardio-Optics, Inc.2006-11-30
K050808CORONARY SINUS ACCESS KIT, MODEL KCS8F-01Cardio-Optics, Inc.2005-07-28
K011793KSEA FIBERSCOPEKARL STORZ Endoscopy-America, Inc.2002-04-17
K012724SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273Smith & Nephew, Inc.2001-11-08
K001408KSEA VASCULAR FIBERSCOPESKARL STORZ Endoscopy-America, Inc.2000-10-30
K964061GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)W. L. Gore & Associates, Inc.1997-02-20
K9526384.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[Baxter Edwards1995-07-28
K951721APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPEApplied Medical Resources1995-07-11
K945591APPLIED MEDICAL OPTICAL VALVULOTOMEApplied Medical Resources1995-02-10
K941715ULTATHIN FLEXIBLE ENDOSCOPETechnology Marketing Group1994-10-04
K934696ANGIOSCOPEIntramed Laboratories, Inc.1994-01-18
K931464BAXTER CORONARY ANGIOSCOPE INFLATION DEVICEBaxter Healthcare Corp1993-10-18
K930758DIAGNOSTIC INTRAVASCULAR CATHETERApplied Medical Resources1993-09-24

Legacy Summary#

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FDA Review#

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