NAVARRE PERCUTANEOUS ACCESS SET— 510(k) K942315

Clearance details

Applicant

Navarre Biomedical , Ltd.

Product code

Code KGZ

Device class

Class 1

Regulation

21 CFR 878.4200

Advisory panel

General, Plastic Surgery

Date received

1994-05-13

Decision date

1994-07-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hamel, MN, 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
• K896087 — PALESTRANT IRRIGATION AND DRAINAGE SET1989-11-03

• K955110 — NAVARRE PERCUTANEOUS BILIARY DRAINAGE1996-11-07
• K955505 — OPTI-DRAIN MULTI-USE DRAINAGE CATHETER1996-02-07
• K945909 — NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER1995-06-02
• K951907 — NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER1995-05-15
• K951475 — NAVARRE UNIVERSAL DRAINAGE CATHETER1995-04-24