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510(k) K881695

DESERET SUBCLAVIAN HEMODIALYSIS CATHETER by Deseret Medical, Inc. — Product Code LFJ

K881695 is an FDA 510(k) premarket notification submitted by Deseret Medical, Inc. for the device "DESERET SUBCLAVIAN HEMODIALYSIS CATHETER". The FDA issued a decision of Substantially Equivalent on June 23, 1988. The device falls under product code LFJ (Catheter, Subclavian), a Class II device regulated under 21 CFR 876.5540. Deseret Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1988
Date Received
April 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Subclavian
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
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)
  • K893406 — DESERET PRN ADAPTER (June 22, 1989)
  • K882797 — LUER-LOK MULTIFLO ADAPTER (July 18, 1988)

Other clearances for product code LFJ

  • K920780 — MEDSURG INSERTION TRAY (August 19, 1994)
  • K925819 — AKCESS0CATH KIT (August 2, 1994)
  • K925818 — AKCESS-CATH (April 5, 1994)
  • K913468 — ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY (March 24, 1994)
  • K931120 — COAXIAL ACUTE CATHETER (January 14, 1994)
  • K920634 — SPLITTABLE SHEATH INTRODUCER SET (January 14, 1994)
  • K914162 — VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS (July 1, 1993)
  • K915423 — HEMO-CATH SILICONE ACCESS CATHETER (February 2, 1993)
  • K914826 — AKCESS-CATH KIT (April 10, 1992)
  • K910501 — PERMANENT SILICONE CATHETERS (April 29, 1991)

FDA data resources