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510(k) K902203

TENCKHOFF PERITONEAL DIALYSIS KIT by Akcess Medical Products, Inc. — Product Code FJG

K902203 is an FDA 510(k) premarket notification submitted by Akcess Medical Products, Inc. for the device "TENCKHOFF PERITONEAL DIALYSIS KIT". The FDA issued a decision of Substantially Equivalent (kit) on August 1, 1990. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. Akcess Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
August 1, 1990
Date Received
May 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Parallel Flow
Device Class
Class II
Regulation Number
876.5820
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)
  • K920634 — SPLITTABLE SHEATH INTRODUCER SET (January 14, 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)

Other clearances for product code FJG

  • K933681 — GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS (September 7, 1994)
  • K933680 — GAMBRO LUNDIA PRO 200 DIALYZER (August 26, 1994)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (September 21, 1992)
  • K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERS (March 6, 1992)
  • K901368 — HEMOSPAL KITS A1, A2D, AO, & A1D (August 2, 1990)
  • K862840 — GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N (September 29, 1986)
  • K853406 — GAMBRO LUNDIA PRO 3 & 5 DIALYZER (January 8, 1986)
  • K820694 — COBE PPD 1.3L, #18-520-009 (March 31, 1982)
  • K812336 — COBE PPD 1.9 (August 31, 1981)
  • K811439 — EXP 200 PARALLEL PLATE DIALYZER (June 12, 1981)

FDA data resources