Cleared Traditional

K852914 - ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION
(FDA 510(k) Clearance)

K852914 · Norton Performance Plastics Corp. · Cardiovascular

Sep 1985

Decision

77d

Days

Class 2

Risk

K852914 is an FDA 510(k) clearance for the ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Norton Performance Plastics Corp. (Akron, US). The FDA issued a Cleared decision on September 25, 1985, 77 days after receiving the submission on July 10, 1985. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K852914 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 1985
Decision Date	September 25, 1985
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—