CARDIMA TRACKER(R) INFUSION CATHETER— 510(k) K932800

Name: FDA 510(k) clearance K932800
Creator: U.S. Food and Drug Administration
Published: 1993-12-21

Substantially Equivalent

Cardima, Inc.

FDA 510(k) clearance K932800 for CARDIMA TRACKER(R) INFUSION CATHETER, Substantially Equivalent on 1993-12-21. Applicant: Cardima, Inc.. Device class: 2.

Clearance details

Applicant: Cardima, Inc.
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 1993-06-09
Decision date: 1993-12-21
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 Cardima, Inc.

view all

K060715 — MODIFICATION TO: CARDIMA ABLATION SYSTEM2006-05-15
K022008 — CARDIMA ABLATION SYSTEM2003-01-29
K974683 — NAVIPORT DEFLECTABLE TIP GUIDING CATHETER1999-06-22
K972803 — TRACER O-T-W MAPPING DEVICE1999-05-11
K982835 — ELECTRODE SWITCHBOX, MODEL 11-0810021998-10-29

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.