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510(k) K920634

SPLITTABLE SHEATH INTRODUCER SET by Akcess Medical Products, Inc. — Product Code LFJ

K920634 is an FDA 510(k) premarket notification submitted by Akcess Medical Products, Inc. for the device "SPLITTABLE SHEATH INTRODUCER SET". The FDA issued a decision of Substantially Equivalent on January 14, 1994. The device falls under product code LFJ (Catheter, Subclavian), a Class II device regulated under 21 CFR 876.5540. Akcess Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1994
Date Received
February 12, 1992
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 Akcess Medical Products, Inc.

  • K926374 — SILICONE CATHETER REPAIR KITS (October 7, 1994)
  • K925819 — AKCESS0CATH KIT (August 2, 1994)
  • K925818 — AKCESS-CATH (April 5, 1994)
  • K930630 — RIGHT ATRIAL CATHETER (February 7, 1994)
  • K931120 — COAXIAL ACUTE CATHETER (January 14, 1994)
  • K914936 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET (April 23, 1992)
  • K920331 — RIGHT ATRIAL CATHETER KITS (April 22, 1992)
  • K914826 — AKCESS-CATH KIT (April 10, 1992)
  • K915215 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS (March 27, 1992)
  • K911333 — RIGHT ATRIAL CATHETERS (September 23, 1991)

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)
  • 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)
  • K905080 — MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER (January 31, 1991)

FDA data resources