Stripper, Vein, External
Cardiovascular · 21 CFR 870.4885
Recent MDR events
106 adverse event reports on file
- PHASTIPP RESECTOR HANDPIECEDec 17, 2025MalfunctionLemaitre Vascular, Inc.1220948-2025-00220
- PHASTIPP DISPOSABLE RESECTORSep 15, 2025MalfunctionLemaitre Vascular, Inc.1220948-2025-00163
- PHASTIPP RESECTOR HANDPIECEApr 9, 2025MalfunctionLemaitre Vascular, Inc.1220948-2025-00062
- PHASTIPP RESECTOR HANDPIECEMar 20, 2025MalfunctionLemaitre Vascular, Inc.1220948-2025-00051
- PHASTIPP RESECTOR HANDPIECEJan 10, 2025MalfunctionLemaitre Vascular, Inc.1220948-2025-00004
- PHASTIPP RESECTOR HANDPIECEDec 13, 2024MalfunctionLemaitre Vascular, Inc.1220948-2024-00247
- PHASTIPP RESECTOR HANDPIECEOct 18, 2024MalfunctionLemaitre Vascular, Inc.1220948-2024-00203
- PHASTIPP RESECTOR HANDPIECEJul 3, 2024MalfunctionLemaitre Vascular, Inc.1220948-2024-00128
- PHASTIPPApr 16, 2024MalfunctionLemaitre Vascular, Inc.1220948-2024-00096
- PHASTIPP DISPOSABLE RESECTORMar 10, 2023MalfunctionLemaitre Vascular, Inc.1220948-2023-00037
Event type breakdown
Recalls
2 recall events for this product code
- LeMaitre Vascular, Inc.TerminatedMar 18, 2015
LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenou
Mislabeled with an incorrect expiration date
Z-1294-2015 · View FDA record ↗ - Smith & Nephew, Inc Endoscopy DivisionTerminatedAug 2, 2007
Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.
Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.
Z-1105-2007 · View FDA record ↗
Registered firms
8 firms currently registered for this product code
Qsa Surgical (pvt) Ltd.
SIALKOT Punjab, PK
Ultimate Medical Products Ltd.
SHARJAH Ash Shariqah, AE
Lemaitre Vascular, Inc.
BURLINGTON, MA, US
Teleflex Medical Llc
Morrisville, NC, US
Sterigenics U.s., Llc
Queensbury, NY, US
Lemaitre Vascular Inc.
Billerica, MA, US
B. Braun Us Device Manufacturing Llc
ALLENTOWN, PA, US
Teleflex Llc (nadc)
Olive Branch, MS, US
510(k) clearances
8 clearances for this product code
- LeMaitre Vascular, Inc.Mar 31, 2022
K212894 · PhasTIPP
- Smith & Nephew, Inc.Jul 22, 2004
K041453 · SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023
- Smith & Nephew, Inc.Oct 29, 2003
K032387 · TRIVEX SYSTEM
- Uresil Corp.Apr 18, 1991
K905528 · URESIL VALVE CUTTER
- Pilling Co.Mar 1, 1991
K904507 · PILLING BRUSH VALVULOTOME
- Aesculap Instruments Corp.Feb 28, 1990
K885046 · INSITUCAT VALVE STRIPPER
- Solco Basle, Inc.Jul 7, 1987
K872157 · HALL VEIN STRIPPER
- Atrium Medical Corp.Jul 20, 1981
K811910 · VEIN-TRAP TM