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510(k) K913129

ANGIOLAZ ANGIOSCOPE CATHETER by Angiolaz, Inc. — Product Code LYK

K913129 is an FDA 510(k) premarket notification submitted by Angiolaz, Inc. for the device "ANGIOLAZ ANGIOSCOPE CATHETER". The FDA issued a decision of Substantially Equivalent on December 27, 1991. The device falls under product code LYK (Angioscope), a Class II device regulated under 21 CFR 876.1500. Angiolaz, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1991
Date Received
July 16, 1991
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 Angiolaz, Inc.

  • K994362 — HEADLAMP HL2000. (May 11, 2000)
  • K992447 — 50 W METAL HALIDE ILLUMINATOR, VES 0501. (October 20, 1999)
  • K982397 — VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM (September 10, 1998)
  • K982409 — VES 1501-M (August 21, 1998)
  • K981819 — ANGIOLAZ VES-1CAM (August 4, 1998)
  • K981821 — VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR (July 29, 1998)
  • K981827 — VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM (July 28, 1998)
  • K933868 — ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES (November 10, 1993)
  • K902329 — ULTRA-VU ANGIOSCOPE (August 22, 1990)

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)
  • 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)

FDA data resources