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510(k) K952638

4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ by Baxter Edwards — Product Code LYK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1995
Date Received
June 9, 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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  • K955839 — MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER (March 25, 1996)
  • K944214 — BAXTER HANDLE MODEL 1150 (February 10, 1995)
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  • K940795 — SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER (May 24, 1994)
  • K926433 — 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 (March 23, 1993)

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  • 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)
  • K951721 — APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE (July 11, 1995)
  • K945591 — APPLIED MEDICAL OPTICAL VALVULOTOME (February 10, 1995)