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510(k) K897153

CVIS INSIGHT IMAGING CATHETER by Cardiovascular Imaging Systems, Inc. — Product Code LYK

K897153 is an FDA 510(k) premarket notification submitted by Cardiovascular Imaging Systems, Inc. for the device "CVIS INSIGHT IMAGING CATHETER". The FDA issued a decision of Substantially Equivalent on Mar 26, 1990. The device falls under product code LYK (Angioscope), a Class II device regulated under 21 CFR 876.1500. Cardiovascular Imaging Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 26, 1990
Date Received
Dec 26, 1989
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 Cardiovascular Imaging Systems, Inc.

  • K970049 — BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULT (Jun 20, 1997)
  • K942231 — MICROVIEW II/MICRORAIL II CATHETERS (Aug 1, 1994)
  • K933517 — AUTOMATIC PULL BACK DEVICE (Oct 15, 1993)
  • K930232 — CVIS INSIGHT IMAGING GUIDE CATHETER (Jul 21, 1993)
  • K924922 — CVIS INSIGHT IMAGING CATHETER (Jun 29, 1993)
  • K930311 — CVIS LONGVIEW (Jun 2, 1993)
  • K921879 — CBIS CATHETER PULL-BACK DEVICE (Jul 16, 1992)
  • K921750 — CVIS INSIGHT III SYSTEM (Jul 13, 1992)
  • K921631 — CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL (Jul 2, 1992)
  • K921148 — CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE (Jun 16, 1992)

Other clearances for product code LYK

  • K253842 — Vena MicroAngioscope™ System (Jan 28, 2026)
  • K251767 — Vena MicroAngioscope™ System (Oct 1, 2025)
  • K062340 — CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM (Nov 30, 2006)
  • K050808 — CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 (Jul 28, 2005)
  • K011793 — KSEA FIBERSCOPE (Apr 17, 2002)
  • K012724 — SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 (Nov 8, 2001)
  • K001408 — KSEA VASCULAR FIBERSCOPES (Oct 30, 2000)
  • K964061 — GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) (Feb 20, 1997)
  • K952638 — 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE (Jul 28, 1995)
  • K951721 — APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE (Jul 11, 1995)

FDA data resources