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510(k) K893406

DESERET PRN ADAPTER by Deseret Medical, Inc. — Product Code KGZ

K893406 is an FDA 510(k) premarket notification submitted by Deseret Medical, Inc. for the device "DESERET PRN ADAPTER". The FDA issued a decision of Substantially Equivalent on June 22, 1989. The device falls under product code KGZ (Accessories, Catheter), a Class I device regulated under 21 CFR 878.4200. Deseret Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1989
Date Received
May 2, 1989
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 Deseret Medical, Inc.

  • K913027 — VESSEL DILATOR (November 27, 1991)
  • K904648 — SAFE SYTE I.V. CATHETER PLACEMENT UNIT (December 14, 1990)
  • K904121 — VIALON OBTURATOR (November 8, 1990)
  • K904122 — INSYTE-A ARTERIAL CATHETERIZATION UNIT (October 4, 1990)
  • K900116 — DESERET OPTIMA INTRAVASCULAR CATHETER (June 18, 1990)
  • K895735 — DESERET MULTILUMEN SUBCLAVIAN CATHETER (May 18, 1990)
  • K895734 — DESERET INTRAVASCULAR CATHETER (April 9, 1990)
  • K894033 — DISPOSABLE CATHETER PRESSURE TRANSDUCER (October 17, 1989)
  • K882797 — LUER-LOK MULTIFLO ADAPTER (July 18, 1988)
  • K882798 — MULTIFLO ADAPTER (July 18, 1988)

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)
  • K942315 — NAVARRE PERCUTANEOUS ACCESS SET (July 8, 1994)
  • K896087 — PALESTRANT IRRIGATION AND DRAINAGE SET (November 3, 1989)
  • K895041 — OPTICAL CATHETER(TM) INTRODUCER SETS (October 16, 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