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510(k) K942315

NAVARRE PERCUTANEOUS ACCESS SET by Navarre Biomedical , Ltd. — Product Code KGZ

K942315 is an FDA 510(k) premarket notification submitted by Navarre Biomedical , Ltd. for the device "NAVARRE PERCUTANEOUS ACCESS SET". The FDA issued a decision of Substantially Equivalent on July 8, 1994. The device falls under product code KGZ (Accessories, Catheter), a Class I device regulated under 21 CFR 878.4200. Navarre Biomedical , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1994
Date Received
May 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Navarre Biomedical , Ltd.

  • K955110 — NAVARRE PERCUTANEOUS BILIARY DRAINAGE (November 7, 1996)
  • K955505 — OPTI-DRAIN MULTI-USE DRAINAGE CATHETER (February 7, 1996)
  • K945909 — NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER (June 2, 1995)
  • K951907 — NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER (May 15, 1995)
  • K951475 — NAVARRE UNIVERSAL DRAINAGE CATHETER (April 24, 1995)
  • K943663 — NAVARRE 600 ML DRAINAGE BAG (September 8, 1994)
  • K933600 — NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS (March 28, 1994)
  • K932391 — NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET (January 27, 1994)

Other clearances for product code KGZ

  • K022306 — AART SILICONE TUBING (October 10, 2002)
  • K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (February 10, 1998)
  • K973183 — WOUND DRAINAGE HOLDER (January 23, 1998)
  • K955433 — DURALASTIC SILICONE TUBING (January 26, 1996)
  • K896087 — PALESTRANT IRRIGATION AND DRAINAGE SET (November 3, 1989)
  • K895041 — OPTICAL CATHETER(TM) INTRODUCER SETS (October 16, 1989)
  • K893406 — DESERET PRN ADAPTER (June 22, 1989)
  • K873009 — CONCEPT SWITCHING STICK (August 17, 1987)
  • K870014 — HCI GENERAL PURPOSE CATHETER STYLET (February 6, 1987)
  • K864115 — TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU (November 7, 1986)

FDA data resources