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510(k) K893438

T SERIES VESSEL TIPS by Akcess Medical Products, Inc. — Product Code FKW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1989
Date Received
May 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tip, Vessel
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)
  • K920634 — SPLITTABLE SHEATH INTRODUCER SET (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)

Other clearances for product code FKW

  • K810257 — VESSEL TIPS, SIZES 13-18 (March 13, 1981)
  • K791645 — VICKERS MEDICAL MODEL 112 TREONIC DC2 (October 2, 1979)