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510(k) K011793

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2002
Date Received
June 8, 2001
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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  • K050808 — CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 (July 28, 2005)
  • 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)
  • K945591 — APPLIED MEDICAL OPTICAL VALVULOTOME (February 10, 1995)