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510(k) K801634

THE VITA 2 DISPOSABLE DIALYZER by Bellco Artifidial Organ Spec., Inc. — Product Code FHS

K801634 is an FDA 510(k) premarket notification submitted by Bellco Artifidial Organ Spec., Inc. for the device "THE VITA 2 DISPOSABLE DIALYZER". The FDA issued a decision of Substantially Equivalent on December 17, 1980. The device falls under product code FHS (Dialyzer, Single Coil), a Class II device regulated under 21 CFR 876.5820. Bellco Artifidial Organ Spec., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1980
Date Received
July 15, 1980
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 Bellco Artifidial Organ Spec., Inc.

  • K801633 — THE BRAVO NEW PARALLEL FLOW DIALYZER (December 18, 1980)
  • K801632 — THE BELLCO FISTULA NEEDLES (August 4, 1980)

Other clearances for product code FHS

  • K812811 — MICROCOIL 80 DIALYZER (December 3, 1981)
  • K811974 — MICROCOIL 150 DIALYZER (September 16, 1981)
  • 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)
  • K761358 — COIL DIALYZER MODEL ALT 140 (January 10, 1977)
  • K760702 — ERI-FLO 900 DIALYZER (November 19, 1976)

FDA data resources