ATLANTIS PV IMAGING CATHETER, MODEL 36456— 510(k) K022860

Name: FDA 510(k) clearance K022860
Creator: U.S. Food and Drug Administration
Published: 2002-11-21

Substantially Equivalent

Boston Scientific, Target

FDA 510(k) clearance K022860 for ATLANTIS PV IMAGING CATHETER, MODEL 36456, Substantially Equivalent on 2002-11-21. Applicant: Boston Scientific, Target. Device class: 2.

Clearance details

Applicant: Boston Scientific, Target
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2002-08-28
Decision date: 2002-11-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITX

view all

K261170 — BA-004CC2026-08-12
K254143 — EM-TECH Passive Ultrasound Probe Strap2026-08-10
K260161 — SmartGuide Disposable Guides and Grids2026-07-30
K262474 — ND Needle Guidance System2026-07-27
K261014 — Accuro® 3S Needle Guide Kit2026-07-24

More clearances from Boston Scientific, Target

view all

K031049 — GUGLIELMI DETACHABLE COIL (GDC)2003-08-01
K031168 — MATRIX STRETCH RESISTANT DETACHABLE COIL2003-05-14
K030475 — GDC STRETCH RESISTANT DETACHABLE COIL2003-03-14
K022357 — TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-8152002-10-16
K021494 — GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-42002-06-06

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.