Cleared Traditional

K992631 - ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
(FDA 510(k) Clearance)

K992631 · Acuson Corp. · Radiology

Dec 1999

Decision

131d

Days

Class 2

Risk

K992631 is an FDA 510(k) clearance for the ACUNAV DIAGNOSTIC ULTRASOUND CATHETER. This device is classified as a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO).

Submitted by Acuson Corp. (Washington, US). The FDA issued a Cleared decision on December 15, 1999, 131 days after receiving the submission on August 6, 1999.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K992631 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 1999
Decision Date	December 15, 1999
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF