ELECTROPHYSIOLOGY CATHETER— 510(k) K030109

Clearance details

Applicant

Alliance Medical Corp.

Product code

Code NLH

Device class

Class 2

Regulation

21 CFR 870.1220

Advisory panel

Cardiovascular

Date received

2003-01-13

Decision date

2003-08-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Phoenix, AZ, US

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• Z-0340-2014 — Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. Note: These devices do not support or sustain life. Diagnostic EP Catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables interface an EP catheter with the appropriate external stimulation or recording equipment or serve as an extension cable between an EP catheter and equipment out of immediate reach. Reprocessed diagnostic electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.Class II·Terminated·Stryker Sustainability Solutions·20131018

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030109.