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510(k) K863936

DUFFY BOLUS INJECTOR by Viox Corp. — Product Code IWR

K863936 is an FDA 510(k) premarket notification submitted by Viox Corp. for the device "DUFFY BOLUS INJECTOR". The FDA issued a decision of Substantially Equivalent on January 6, 1987. The device falls under product code IWR (Holder, Syringe, Lead), a Class I device regulated under 21 CFR 892.6500. Viox Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1987
Date Received
October 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Syringe, Lead
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances by Viox Corp.

  • K872656 — LEAD GLASS SHIELDS (July 16, 1987)

Other clearances for product code IWR

  • K934549 — ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD (February 19, 1994)
  • K872656 — LEAD GLASS SHIELDS (July 16, 1987)
  • K811688 — TUNGSTEN SYRINGE SHIELD (July 2, 1981)

FDA data resources