Home / 510(k) Clearances / K251211

510(k) K251211

ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ by Abbott Medical — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2025
Date Received
April 18, 2025
Clearance Type
Special
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 Abbott Medical

  • K260499 — Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609- (March 13, 2026)
  • K252512 — Armada™ 14 NC PTA Catheter (February 13, 2026)
  • K253516 — Assert-IQ (DM5100) (December 18, 2025)
  • K252417 — Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (December 17, 2025)
  • K253232 — Seguin Annuloplasty Ring (October 29, 2025)
  • K250031 — Amplatzer Guidewire (October 3, 2025)
  • K252013 — EnSite™ X EP System (September 25, 2025)
  • K251463 — EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X (September 4, 2025)
  • K251234 — EnSite™ X EP System (July 30, 2025)
  • K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (July 25, 2025)

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)
  • 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)
  • K233270 — AcuNav Crystal Ultrasound Catheter (October 28, 2023)