Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- LYKAngioscope2Product Code
- 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)
Show All 39 Submissions
- 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
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K062340
- 510(k) Type
- Traditional
- Applicant
- CARDIO-OPTICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/30/2006
- Days to Decision
- 112 days
- Submission Type
- Summary