Cleared Traditional

PILLING BRUSH VALVULOTOME

K904507 · Pilling Co. · Cardiovascular
Mar 1991
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K904507 is an FDA 510(k) clearance for the PILLING BRUSH VALVULOTOME, a Stripper, Vein, External (Class II — Special Controls, product code DWQ), submitted by Pilling Co. (Fort Washington, US). The FDA issued a Cleared decision on March 1, 1991, 150 days after receiving the submission on October 2, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number K904507 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 1990
Decision Date March 01, 1991
Days to Decision 150 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DWQ — Stripper, Vein, External
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4885