DWQ · Class II · 21 CFR 870.4885

FDA Product Code DWQ: Stripper, Vein, External

Leading manufacturers include Smith & Nephew, Inc., LeMaitre Vascular, Inc. and Atrium Medical Corp..

8
Total
8
Cleared
140d
Avg days
1981
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Stripper, Vein, External Devices (Product Code DWQ)

8 devices
1–8 of 8
Cleared Mar 31, 2022
PhasTIPP
K212894
LeMaitre Vascular, Inc.
Cardiovascular · 202d
Cleared Jul 22, 2004
SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023
K041453
Smith & Nephew, Inc.
Cardiovascular · 51d
Cleared Oct 29, 2003
TRIVEX SYSTEM
K032387
Smith & Nephew, Inc.
Cardiovascular · 86d
Cleared Apr 18, 1991
URESIL VALVE CUTTER
K905528
Uresil Corp.
Cardiovascular · 129d
Cleared Mar 01, 1991
PILLING BRUSH VALVULOTOME
K904507
Pilling Co.
Cardiovascular · 150d
Cleared Feb 28, 1990
INSITUCAT VALVE STRIPPER
K885046
Aesculap Instruments Corp.
Cardiovascular · 450d
Cleared Jul 07, 1987
HALL VEIN STRIPPER
K872157
Solco Basle, Inc.
Cardiovascular · 33d
Cleared Jul 20, 1981
VEIN-TRAP TM
K811910
Atrium Medical Corp.
Cardiovascular · 19d

About Product Code DWQ - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code DWQ since 1981, with 8 receiving FDA clearance (average review time: 140 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.