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510(k) K934549

ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD by Victoreen, Inc. — Product Code IWR

K934549 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD". The FDA issued a decision of Substantially Equivalent on February 19, 1994. The device falls under product code IWR (Holder, Syringe, Lead), a Class I device regulated under 21 CFR 892.6500. Victoreen, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1994
Date Received
September 22, 1993
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 Victoreen, Inc.

  • K982937 — MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER (November 19, 1998)
  • K974112 — VACUDAP, MODEL 2000, 2001 (January 29, 1998)
  • K973960 — MODEL 37-185 (January 14, 1998)
  • K964952 — VERIDOSE V (FIVE), MODEL NUMBER 37-705 (July 21, 1997)
  • K964785 — VERIDOSE DIODES (June 13, 1997)
  • K971382 — PRONE BREAST POSITIONING BOARD, MODEL #37-018 (June 6, 1997)
  • K952233 — CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 (June 16, 1995)
  • K940660 — MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM (December 9, 1994)
  • K935435 — NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST (July 29, 1994)
  • K941931 — DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR (May 26, 1994)

Other clearances for product code IWR

  • K872656 — LEAD GLASS SHIELDS (July 16, 1987)
  • K863936 — DUFFY BOLUS INJECTOR (January 6, 1987)
  • K811688 — TUNGSTEN SYRINGE SHIELD (July 2, 1981)

FDA data resources