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510(k) K951721

APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE by Applied Medical Resources — Product Code LYK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1995
Date Received
April 14, 1995
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

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  • 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)
  • K945591 — APPLIED MEDICAL OPTICAL VALVULOTOME (February 10, 1995)