LYK

Product Code: LYK


Products Classified as LYK

998AngioscopeEndoscope And Accessories.

Total Product Life Cycle (TPLC) Devices

998AngioscopeEndoscope And Accessories.

FDA Consensus Standards

Angioscope [32386]21 CFR §876.1500 🔎
Angioscope [30564]21 CFR §876.1500 🔎
Angioscope [30563]21 CFR §876.1500 🔎
Angioscope [33513]21 CFR §876.1500 🔎
Angioscope [31951]21 CFR §876.1500 🔎

Pre-market Notifications for LYK

K062340CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEMCARDIO-OPTICS, INC.
K050808CORONARY SINUS ACCESS KIT, MODEL KCS8F-01CARDIO-OPTICS, INC.
K011793KSEA FIBERSCOPEKARL STORZ ENDOSCOPY-AMERICA, INC.
K001408KSEA VASCULAR FIBERSCOPESKARL STORZ ENDOSCOPY-AMERICA, INC.
K964061GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)W.L. GORE & ASSOCIATES,INC
K9526384.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[BAXTER EDWARDS
K951721APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPEAPPLIED MEDICAL RESOURCES
K945591APPLIED MEDICAL OPTICAL VALVULOTOMEAPPLIED MEDICAL RESOURCES
K941715ULTATHIN FLEXIBLE ENDOSCOPETECHNOLOGY MARKETING GROUP
K934696ANGIOSCOPEINTRAMED LABORATORIES, INC.
K931421DISPOSABLE STEERABLE ANGIOSCOPEENDOVASCULAR, INC.
K930758DIAGNOSTIC INTRAVASCULAR CATHETERAPPLIED MEDICAL RESOURCES
K9264334.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45BAXTER EDWARDS
K924554CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPECLARUS MEDICAL SYSTEMS, INC.
K923996DISPOSABLE VASCULAR ANGIOSCOPEENDOVASCULAR, INC.

Maude Adverse Events

1.7MM 0.8MM 100CM DISPOSABLE ANGIOSCOPESAPPLIED MEDICAL RESOURCES2017-03-09
2.3MM 1.0MM 80CM DISPOSABLE ANGIOSCOPEAPPLIED MEDICAL2013-10-11
2.3MM DISPOSABLE ANGIOSCOPEAPPLIED MEDICAL2013-08-12
OLYMPUS EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORPORATION2010-04-13
ANGIOSCOPE (DISPOSABLE)EDWARDS LIFE SCIENCE2005-03-29
2.3MM REUSABLE ANGIOSCOPEAPPLIED MEDICAL RESOURCES1997-05-10

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