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510(k) K253842

Vena MicroAngioscope™ System by Vena Medical Holdings Corp — Product Code LYK

K253842 is an FDA 510(k) premarket notification submitted by Vena Medical Holdings Corp for the device "Vena MicroAngioscope™ System". The FDA issued a decision of Substantially Equivalent on January 28, 2026. The device falls under product code LYK (Angioscope), a Class II device regulated under 21 CFR 876.1500. Vena Medical Holdings Corp has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2026
Date Received
December 2, 2025
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 Vena Medical Holdings Corp

  • K251767 — Vena MicroAngioscope™ System (October 1, 2025)

Other clearances for product code LYK

  • 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)
  • K945591 — APPLIED MEDICAL OPTICAL VALVULOTOME (February 10, 1995)

FDA data resources