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510(k) K200195

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter by Northeast Scientific, Inc. — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2020
Date Received
January 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ultrasound, Intravascular
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

Other clearances by Northeast Scientific, Inc.

  • K250592 — NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (May 12, 2025)
  • K223026 — NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (February 3, 2023)
  • K220171 — NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter (July 1, 2022)
  • K090661 — NES REPROCESSED VARICOSE VEIN RF CATHETER (July 21, 2010)
  • K060676 — NES REPROCESSED ENDOSCOPIC TROCAR (September 7, 2007)

Other clearances for product code OBJ

  • K253399 — Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Cathe (October 28, 2025)
  • K250955 — XC11 ICE System, USA (October 22, 2025)
  • K250913 — TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System (July 19, 2025)
  • K251211 — ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD (May 23, 2025)
  • K251231 — ViewFlex™ X ICE Catheter, Sensor Enabled™ (May 20, 2025)
  • K251103 — VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intrac (May 9, 2025)
  • K242893 — VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (March 24, 2025)
  • K241540 — NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (June 28, 2024)
  • K240050 — SOUNDSTAR™ CRYSTAL Ultrasound Catheter (June 12, 2024)
  • K233948 — Provisio™ SLT IVUS™ System (April 23, 2024)