Cleared Traditional

K922787 - ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION
(FDA 510(k) Clearance)

K922787 · Echocath, Inc. · Cardiovascular

Jan 1993

Decision

211d

Days

Class 2

Risk

K922787 is an FDA 510(k) clearance for the ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION. This device is classified as a Wire, Guide, Catheter (Class II — Special Controls, product code DQX).

Submitted by Echocath, Inc. (Princeton, US). The FDA issued a Cleared decision on January 6, 1993, 211 days after receiving the submission on June 9, 1992.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number	K922787 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 1992
Decision Date	January 06, 1993
Days to Decision	211 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF