Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- LYKAngioscope2Product Code
- K251767Vena MicroAngioscope™ System2Cleared 510(K)
- K062340CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM2Cleared 510(K)
- K050808CORONARY SINUS ACCESS KIT, MODEL KCS8F-012Cleared 510(K)
- K011793KSEA FIBERSCOPE2Cleared 510(K)
- K012724SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 72092732Cleared 510(K)
- K001408KSEA VASCULAR FIBERSCOPES2Cleared 510(K)
- K964061GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)2Cleared 510(K)
- K9526384.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[2Cleared 510(K)
- K951721APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE2Cleared 510(K)
- K945591APPLIED MEDICAL OPTICAL VALVULOTOME2Cleared 510(K)
- K941715ULTATHIN FLEXIBLE ENDOSCOPE2Cleared 510(K)
- K934696ANGIOSCOPE2Cleared 510(K)
- K931464BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE2Cleared 510(K)
- K930758DIAGNOSTIC INTRAVASCULAR CATHETER2Cleared 510(K)
- K931421DISPOSABLE STEERABLE ANGIOSCOPE2Cleared 510(K)
- K9264334.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV452Cleared 510(K)
- K924554CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE2Cleared 510(K)
- K923996DISPOSABLE VASCULAR ANGIOSCOPE2Cleared 510(K)
- K905745AMETEC MASY MODULAR ANGIOSCOPE SYSTEM2Cleared 510(K)
- K914570DISPOSABLE VASCULAR ANGIOSCOPE2Cleared 510(K)
- K913129ANGIOLAZ ANGIOSCOPE CATHETER2Cleared 510(K)
- K913763INTERPRET(TM) CATHETER LINEAR TRANSLATOR2Cleared 510(K)
- K911090OMEGA ANGIOSCOPES (OMEGASCOPES)2Cleared 510(K)
- K911278OLYMPUS AF ANGIOSCOPE SYSTEM2Cleared 510(K)
- K9050834.5F IMAGECATH ANGIOSCOPE2Cleared 510(K)
- K902329ULTRA-VU ANGIOSCOPE2Cleared 510(K)
- K895538ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY2Cleared 510(K)
- K900305INTRAVASCULAR IMAGING SYSTEMS2Cleared 510(K)
- K897153CVIS INSIGHT IMAGING CATHETER2Cleared 510(K)
- K895159INTRAVASCULAR IMAGING SYSTEM2Cleared 510(K)
- K894459ANGIOSCOPE2Cleared 510(K)
- K893816HEMOLASER HEMOSCOPE2Cleared 510(K)
- K890047VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM2Cleared 510(K)
- K883000ACS ANGIOSCOPE GUIDE WIRE2Cleared 510(K)
- K875108ACS CORONARY ANGIOSCOPIC CATHETER2Cleared 510(K)
- K860858OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE2Cleared 510(K)
- K842481AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE2Cleared 510(K)
- K834547ANGIOSCOPY CATHETER2Cleared 510(K)
- K832698ANGIOSCOPY CATHETER2Cleared 510(K)
- K830084ANGIOSCOPE2Cleared 510(K)
- PZOSoftware For Visualization Of Vascular Anatomy And Intravascular Devices2Product Code
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
OMEGA ANGIOSCOPES (OMEGASCOPES)
- Page Type
- Cleared 510(K)
- 510(k) Number
- K911090
- 510(k) Type
- Traditional
- Applicant
- OMEGA UNIVERSAL TECHNOLOGIES, LTD.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/31/1991
- Days to Decision
- 142 days