MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM— 510(k) K032390

Name: FDA 510(k) clearance K032390
Creator: U.S. Food and Drug Administration
Published: 2003-08-29

Substantially Equivalent

Ebi, L.P.

FDA 510(k) clearance K032390 for MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM, Substantially Equivalent on 2003-08-29. Applicant: Ebi, L.P.. Device class: 2.

Clearance details

Applicant: Ebi, L.P.
Product code: Code BSO
Device class: Class 2
Regulation: 21 CFR 868.5120
Advisory panel: Anesthesiology
Date received: 2003-08-04
Decision date: 2003-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSO

view all

K241410 — EDEN ControlCath2025-02-13
K231242 — Perifix FX Catheter; Contiplex FX Catheter2023-09-15
K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C) +4 more2023-08-30
K193664 — SubQKath Catheter and Needle Set2020-09-09
K200624 — Percutaneous Introducer2020-04-27

More clearances from Ebi, L.P.

view all

K100438 — POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM2010-06-23
K100220 — POLARIS SPINAL SYSTEM2010-05-17
K093880 — PEANUT GROWTH CONTROL PLATING SYSTEM2010-04-16
K092574 — ESL SPINAL SYSTEM2010-02-04
K093057 — BIOMET VISION FOOTRING SYSTEM2009-12-01

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.