Cleared Traditional

K971397 - VIEWCATH 3-D CATHETER PULLBACK
(FDA 510(k) Clearance)

K971397 · Quinton, Inc. · Radiology

Aug 1997

Decision

132d

Days

Class 2

Risk

K971397 is an FDA 510(k) clearance for the VIEWCATH 3-D CATHETER PULLBACK, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Quinton, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 25, 1997, 132 days after receiving the submission on April 15, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number	K971397 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 1997
Decision Date	August 25, 1997
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF