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510(k) K050808

CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 by Cardio-Optics, Inc. — Product Code LYK

K050808 is an FDA 510(k) premarket notification submitted by Cardio-Optics, Inc. for the device "CORONARY SINUS ACCESS KIT, MODEL KCS8F-01". The FDA issued a decision of Substantially Equivalent on July 28, 2005. The device falls under product code LYK (Angioscope), a Class II device regulated under 21 CFR 876.1500. Cardio-Optics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2005
Date Received
March 30, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Angioscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
CV
Submission Type

Other clearances by Cardio-Optics, Inc.

  • K062340 — CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM (November 30, 2006)

Other clearances for product code LYK

  • K253842 — Vena MicroAngioscope™ System (January 28, 2026)
  • K251767 — Vena MicroAngioscope™ System (October 1, 2025)
  • K062340 — CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM (November 30, 2006)
  • K011793 — KSEA FIBERSCOPE (April 17, 2002)
  • K012724 — SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 (November 8, 2001)
  • K001408 — KSEA VASCULAR FIBERSCOPES (October 30, 2000)
  • K964061 — GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) (February 20, 1997)
  • K952638 — 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE (July 28, 1995)
  • K951721 — APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE (July 11, 1995)
  • K945591 — APPLIED MEDICAL OPTICAL VALVULOTOME (February 10, 1995)

FDA data resources