Cleared Traditional

MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE

K911099 · Pilling Co. · Cardiovascular
Jun 1991
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K911099 is an FDA 510(k) clearance for the MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE, a Stripper, Artery, Intraluminal (Class II — Special Controls, product code DWX), submitted by Pilling Co. (Fort Washington, US). The FDA issued a Cleared decision on June 25, 1991, 105 days after receiving the submission on March 12, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K911099 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 1991
Decision Date June 25, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DWX — Stripper, Artery, Intraluminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4875

Similar Devices — DWX Stripper, Artery, Intraluminal

All 13
MOLLRING MULTITASC
K121415 · LeMaitre Vascular, Inc. · Sep 2012
ENDOHELIX ENDARTERECTOMY DEVICE
K032105 · Endarx, Inc. · Oct 2003
CARBODISSECTING ENDOSCOPE
K020925 · Endo Surgical Devices, Inc. · Apr 2003
VASCULAR ARCHITECTS PERISCOPE DEVICE
K003719 · Vascular Architects, Inc. · Feb 2001
MOLLRING CUTTER
K950813 · Cardio Vascular Concepts, Inc. · Jul 1995
EXTERNAL VEIN STRIPPER
K933498 · Applied Medical Resources · Mar 1994