Cleared Traditional

ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER

K933417 · Echocath, Inc. · Cardiovascular

May 1995

Decision

660d

Days

Class 2

Risk

About This 510(k) Submission

K933417 is an FDA 510(k) clearance for the ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Echocath, Inc. (Princeton, US). The FDA issued a Cleared decision on May 4, 1995, 660 days after receiving the submission on July 13, 1993. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K933417 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 1993
Decision Date	May 04, 1995
Days to Decision	660 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1220