ANGIOLAPCATH CHOLANGIOGRAPHY KIT— 510(k) K926143

Clearance details

Applicant

Bd Becton Dickinson Vacutainer Systems Preanalytic

Product code

Code GBZ

Device class

Class 1

Regulation

21 CFR 878.4200

Advisory panel

General, Plastic Surgery

Date received

1992-12-07

Decision date

1993-07-07

Decision

Unknown

Clearance type

Traditional

Location

Franklin Lakes, NJ, US

• K973621 — PRE-VIEW CHOLANGIOGRAPHY CLAMP1997-12-17
• K944790 — FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER1994-11-29
• K942450 — ENDOPATH1994-08-05
• K932228 — MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER1993-08-10
• K926217 — TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE1993-07-13

• K003062 — BACTEC MGIT 960 SIR KITS2001-06-06
• K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2001-03-21
• K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE2001-02-01
• K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/162000-11-29
• K001364 — BD DIRECTIGEN FLU A+B2000-06-28

Death

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →