Home / 510(k) Clearances / K761358

510(k) K761358

COIL DIALYZER MODEL ALT 140 by Bentley Laboratories, Inc. — Product Code FHS

K761358 is an FDA 510(k) premarket notification submitted by Bentley Laboratories, Inc. for the device "COIL DIALYZER MODEL ALT 140". The FDA issued a decision of Substantially Equivalent on January 10, 1977. The device falls under product code FHS (Dialyzer, Single Coil), a Class II device regulated under 21 CFR 876.5820. Bentley Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1977
Date Received
December 29, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Single Coil
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Bentley Laboratories, Inc.

  • K931967 — HE-30 GOLD (July 13, 1993)
  • K913956 — BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 (January 17, 1992)
  • K913692 — VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) (November 15, 1991)
  • K903641 — QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q (November 9, 1990)
  • K894826 — UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF (February 28, 1990)
  • K874867 — CATR(TM)-H CARDIOTOMY HOLDER (February 2, 1988)
  • K874841 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (February 2, 1988)
  • K874618 — BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER (January 19, 1988)
  • K823359 — OXYGEN CONSUMPTION MONITOR #OCM-0100 (January 5, 1983)
  • K823273 — BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. (January 5, 1983)

Other clearances for product code FHS

  • K812811 — MICROCOIL 80 DIALYZER (December 3, 1981)
  • K811974 — MICROCOIL 150 DIALYZER (September 16, 1981)
  • K801634 — THE VITA 2 DISPOSABLE DIALYZER (December 17, 1980)
  • K800723 — MICRO-COIL 100 COIL DIALYZER (May 14, 1980)
  • K800174 — GAMBRO LUNDIA COIL DIALYZER (February 13, 1980)
  • K790223 — DIALYZER, CD-800 COIL (March 26, 1979)
  • K781102 — DIALYZER, DISP., COIL, LUNDIA (October 17, 1978)
  • K771349 — MODIFICATION TO KIDNEY DIALYZER (August 2, 1977)
  • K770735 — DIALYZER, COIL, CD, LSA, 5M1765 (May 10, 1977)
  • K760702 — ERI-FLO 900 DIALYZER (November 19, 1976)

FDA data resources