EXCELSIOR 1018 MICROCATHETER— 510(k) K994155

Name: FDA 510(k) clearance K994155
Creator: U.S. Food and Drug Administration
Published: 2000-08-03

Substantially Equivalent

Boston Scientific, Target

FDA 510(k) clearance K994155 for EXCELSIOR 1018 MICROCATHETER, Substantially Equivalent on 2000-08-03. Applicant: Boston Scientific, Target. Device class: 2.

Clearance details

Applicant: Boston Scientific, Target
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 1999-12-09
Decision date: 2000-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRA

view all

K254051 — Extroducer Infusion Catheter System2026-09-11
K261610 — Verge Microcatheter2026-06-11
K260771 — TruSelect 2.6 Microcatheter2026-05-15
K250794 — InVera Infusion Device2026-03-12
K243534 — Micro Catheter2025-07-30

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
K022860 — ATLANTIS PV IMAGING CATHETER, MODEL 364562002-11-21
K022357 — TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-8152002-10-16

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.