ViewFlex Xtra ICE Catheter +5 more— 510(k) K251211

Name: FDA 510(k) clearance K251211
Creator: U.S. Food and Drug Administration
Published: 2025-05-23

Substantially Equivalent

ABBOTT MEDICAL

FDA 510(k) clearance K251211 for ViewFlex Xtra ICE Catheter +5 more, Substantially Equivalent on 2025-05-23. Applicant: ABBOTT MEDICAL. Device class: 2.

Clearance details

Device name as filed: 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
Applicant: ABBOTT MEDICAL
Product code: Product code OBJ
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2025-04-18
Decision date: 2025-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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K253399 — Visions® PV .014P RX Digital IVUS Catheter; Visions® PV .018 Digital IVUS Catheter2025-10-28

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Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.