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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

K952638 is an FDA 510(k) premarket notification submitted by Baxter Edwards for the device "4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[". The FDA issued a decision of Substantially Equivalent on July 28, 1995. The device falls under product code LYK (Angioscope), a Class II device regulated under 21 CFR 876.1500. Baxter Edwards has at least 10 other 510(k) clearances on record.

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

Other clearances by Baxter Edwards

  • K993816 — BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND P (May 4, 2000)
  • K981909 — BAXTER HEMOSTASIS VALVE INTRODUCERS (November 24, 1998)
  • K980487 — CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4 (July 7, 1998)
  • K965137 — FOGARTY VALVULOTOME MODEL 700091 (June 4, 1997)
  • K964021 — INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) (March 27, 1997)
  • K955839 — MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER (March 25, 1996)
  • K944214 — BAXTER HANDLE MODEL 1150 (February 10, 1995)
  • K944858 — BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS (January 5, 1995)
  • K940795 — SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER (May 24, 1994)
  • K926433 — 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 (March 23, 1993)

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

FDA data resources