NEOLEAD— 510(k) K011564

Name: FDA 510(k) clearance K011564
Creator: U.S. Food and Drug Administration
Published: 2002-01-03

Substantially Equivalent

Neotech Products, Inc.

FDA 510(k) clearance K011564 for NEOLEAD, Substantially Equivalent on 2002-01-03. Applicant: Neotech Products, Inc.. Device class: 2.

Clearance details

Applicant: Neotech Products, Inc.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 2001-05-21
Decision date: 2002-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRX

view all

K171244 — Physiotrace2017-08-23
K140096 — HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE2014-07-24
K123658 — BIOMODULE 3-M12013-04-24
K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES2010-07-22
K101685 — IP-SET2010-07-01

More clearances from Neotech Products, Inc.

view all

K931727 — URINARY DRAINAGE BAG CADDY1993-07-23
K921024 — URO-TOTE LEG BAG1992-09-02
K890425 — NEOTECH MUCUS TRAP W/CATHETER1989-04-19
K882203 — NEOTECH UNIVERSAL ADAPTER1988-06-17
K880487 — NEOTECH MECONIUM ASPIRATOR (STERILE)1988-05-06

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.