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510(k) K001408

KSEA VASCULAR FIBERSCOPES by KARL STORZ Endoscopy-America, Inc. — Product Code LYK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2000
Date Received
May 4, 2000
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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  • 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)