MEDCOMP T-3— 510(k) K033570

Name: FDA 510(k) clearance K033570
Creator: U.S. Food and Drug Administration
Published: 2004-09-16

Substantially Equivalent

Medcomp

FDA 510(k) clearance K033570 for MEDCOMP T-3, Substantially Equivalent on 2004-09-16. Applicant: Medcomp. Device class: 2.

Clearance details

Applicant: Medcomp
Product code: Code NIE
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2003-11-12
Decision date: 2004-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harleysville, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NIE

view all

K232945 — Trio-CT® Triple Lumen Catheter w/ Curved Extensions2023-11-16
K222170 — Power Acute Triple Lumen Hemodialysis Catheter2023-01-13
K183219 — Trio-CT Triple Lumen Catheter2019-06-14
K181175 — 12F Tri-Flow Triple Lumen Catheter2018-07-05
K143102 — Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions2015-07-24

More clearances from Medcomp

view all

K130889 — SPLIT CATH RG2014-04-28
K123292 — T32013-06-11
K102966 — 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC2010-12-21
K091954 — MICRO-STICK SET2010-01-08
K091953 — PRO-PICC2009-09-16

Adverse events under product code NIE

product code NIE

Death: 9
Other: 1
Total: 10

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.