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510(k) K895159

INTRAVASCULAR IMAGING SYSTEM by Intertherapy, Inc. — Product Code LYK

K895159 is an FDA 510(k) premarket notification submitted by Intertherapy, Inc. for the device "INTRAVASCULAR IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 12, 1990. The device falls under product code LYK (Angioscope), a Class II device regulated under 21 CFR 876.1500. Intertherapy, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1990
Date Received
August 23, 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 Intertherapy, Inc.

  • K913763 — INTERPRET(TM) CATHETER LINEAR TRANSLATOR (November 20, 1991)
  • K912600 — INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER (November 19, 1991)
  • K910281 — INTRAVASCULAR IMAGING SYSTEM/MODIFIED (May 13, 1991)
  • K900305 — INTRAVASCULAR IMAGING SYSTEMS (April 20, 1990)

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)
  • K050808 — CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 (July 28, 2005)
  • 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)

FDA data resources