Cleared Traditional

PARODI CATHETER FOR ANGIOGRAPHY (PARCA)

K001917 · Arteria Medical Science, Inc. · Cardiovascular

Jun 2001

Decision

348d

Days

Class 2

Risk

About This 510(k) Submission

K001917 is an FDA 510(k) clearance for the PARODI CATHETER FOR ANGIOGRAPHY (PARCA), a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Arteria Medical Science, Inc. (Redmond, US). The FDA issued a Cleared decision on June 6, 2001, 348 days after receiving the submission on June 23, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K001917 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2000
Decision Date	June 06, 2001
Days to Decision	348 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF