Product code LBW— Gastroenterology, Urology

COAXIAL DUAL FLOW CATHETER

Classification name: Set, Dialysis, Single Needle (Co-Axial Flow)
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Total cleared: 5
First cleared: 1980-09-26
Most recent: 1990-11-23

Market context for product code LBW

FDA has cleared 5 devices under product code LBW between 1980 and 1990, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19901 clearance
19862 clearances
19821 clearance
19801 clearance

Top applicants under product code LBW

Quinton, Inc.2 clearances
Terumo Medical Corp.1 clearance
Medical Components, Inc.1 clearance
Akcess Medical Products, Inc.1 clearance

Recent clearances under product code LBW

K904433 — DUAL LUMEN NEEDLESAkcess Medical Products, Inc.·1990-11-23
K864629 — MODIFIED DUAL LUMEN NEEDLEQuinton, Inc.·1986-12-16
K860515 — DUAL LUMEN NEEDLE (PRODUCT CHANGE)Quinton, Inc.·1986-03-04
K820859 — COAXIAL DUAL FLOW CATHETERTerumo Medical Corp.·1982-04-16
K801968 — HEMOCATH I KIDNEY DIALYSIS CATHETERMedical Components, Inc.·1980-09-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.