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
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CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K050808
- 510(k) Type
- Traditional
- Applicant
- CARDIO-OPTICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/28/2005
- Days to Decision
- 120 days
- Submission Type
- Summary