STOPCOCKS— 510(k) K760383

Clearance details

Applicant

B. Braun Instruments

Product code

Code KGZ

Device class

Class 1

Regulation

21 CFR 878.4200

Advisory panel

General, Plastic Surgery

Date received

1976-08-05

Decision date

1976-11-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• K022306 — AART SILICONE TUBING2002-10-10
• K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING1998-02-10
• K973183 — WOUND DRAINAGE HOLDER1998-01-23
• K955433 — DURALASTIC SILICONE TUBING1996-01-26
• K942315 — NAVARRE PERCUTANEOUS ACCESS SET1994-07-08

• K760380 — INTRAVENOUS TRANSFER SET (INTRAFIX)1976-11-02
• K760381 — BLOOD TRANSFUSION SET (SANGOFIX)1976-11-02
• K760382 — CONNECTORS1976-11-02
• K760384 — STOPPERS1976-11-02
• K760385 — EXTENSION SETS1976-11-02

• Z-0679-2026 — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. PB1500 15 DROP IV SET W/2 STOPCOCKS; Catalog Number: 490025.Class II·Ongoing·B Braun Medical Inc·20251029
• Z-0680-2026 — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1503 15 DR UNIV SPIKE, INJ SITE, BCV; Catalog Number: 490062.Class II·Ongoing·B Braun Medical Inc·20251029
• Z-0681-2026 — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/10 DROPS, 138 IN.; Catalog Number: 490426.Class II·Ongoing·B Braun Medical Inc·20251029
• Z-0987-2014 — SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.Class II·Terminated·B. Braun Medical, Inc.·20140108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K760383.