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510(k) K840253

ONE-WAY AIR VALVE by Delta Medical Industries — Product Code BYZ

K840253 is an FDA 510(k) premarket notification submitted by Delta Medical Industries for the device "ONE-WAY AIR VALVE". The FDA issued a decision of Substantially Equivalent on April 5, 1984. The device falls under product code BYZ (Trap, Sterile Specimen), a Class II device regulated under 21 CFR 880.6740. Delta Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1984
Date Received
January 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trap, Sterile Specimen
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Delta Medical Industries

  • K833884 — ISOTEC DISPOS. PRESSURE TRANSDUCER (April 17, 1984)
  • K832470 — INFUSION PUMP (February 28, 1984)
  • K830389 — ACCU-RYNGE PUMP SP-250 (September 12, 1983)
  • K831750 — PM-3 (July 26, 1983)
  • K822761 — DELIVERY TUBE SET #2226 (September 30, 1982)
  • K820912 — PMS-2 PRESSURE MONITOR SEPARATOR (May 18, 1982)
  • K820482 — ACCU-RYNGE INSULIN PUMP #SP-250 (March 26, 1982)
  • K810068 — PEDIATRIC ARTERIAL BLOOD FILTER (January 22, 1981)
  • K802755 — ARTERIAL BLOOD FILTER BF-37 (January 7, 1981)
  • K803102 — ARTERIAL BUBBLE TRAP K-20 (December 22, 1980)

Other clearances for product code BYZ

  • K925412 — ELECTROMEDICS TISSUE TRAP/ #TT280 (February 5, 1993)
  • K913643 — MUCOUS SPECIMEN TRAP (October 10, 1991)
  • K902883 — TISSUE/POLYP TRAP SYSTEM (September 12, 1990)
  • K841409 — BUSH NECK W/PLUG (April 18, 1984)
  • K834467 — SPECIMEN TRAP (February 17, 1984)
  • K822557 — SPECIMEN ADAPTOR (October 18, 1982)
  • K822556 — CRITICAL MEASUREMENT UNIT (October 18, 1982)
  • K791847 — ASPRI-LUKE (October 2, 1979)

FDA data resources