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510(k) K905745

AMETEC MASY MODULAR ANGIOSCOPE SYSTEM by American Medical Technology, Inc. — Product Code LYK

K905745 is an FDA 510(k) premarket notification submitted by American Medical Technology, Inc. for the device "AMETEC MASY MODULAR ANGIOSCOPE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 23, 1992. The device falls under product code LYK (Angioscope), a Class II device regulated under 21 CFR 876.1500. American Medical Technology, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1992
Date Received
December 24, 1990
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 American Medical Technology, Inc.

  • K963808 — CHOICE POWERED WHEELCHAIR (February 12, 1997)
  • K874567 — RESUSCITATOR (February 29, 1988)
  • K874430 — NEEDLE CONTAINER (January 4, 1988)
  • K874360 — PLASTIC TUBING CONNECTOR (November 17, 1987)
  • K873313 — SURGICAL DRAPE (September 4, 1987)

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