STERILE LEMAITRE GLOW 'N TELL TAPE— 510(k) K932184

Clearance details

Applicant

Vascutech, Inc.

Product code

Code KFX

Device class

Class 2

Regulation

21 CFR 890.3500

Advisory panel

Physical Medicine

Date received

1993-05-05

Decision date

1993-07-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

North Andover, MA, US

• K833868 — IPOS G.L.P. SYSTEM1983-11-28
• K830285 — REGNELL HYDRAULIC FEMORAL PROTHESIS1983-03-09
• K822240 — ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.1982-12-30

• K001621 — DARDIK CAROTID SHUNT2000-12-06
• K992942 — LEMAITRE OCCLUSION CATHETER2000-04-13
• K992933 — LEMAITRE IRRIGATION CATHETER2000-03-08
• K992934 — LEMAITRE VENOUS THROMBECTOMY CATHETER2000-03-01
• K992940 — LEMAITRE BALLOON CATHETER WITH IRRIGATION2000-02-22

• Z-1054-2013 — LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.Class II·Terminated·LeMaitre Vascular, Inc.·20130318
• Z-1055-2013 — Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.Class II·Terminated·LeMaitre Vascular, Inc.·20130318

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K932184.