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510(k) K010406

JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G by Jms Co., Ltd. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2001
Date Received
February 12, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Jms Co., Ltd.

  • K002352 — JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE (September 6, 2001)
  • K002394 — JMS APHERESIS NEEDLE SET ACCORDION TYPE (September 5, 2001)
  • K010410 — JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G (June 20, 2001)
  • K000843 — MODIFICATION TO JMS APHERESIS NEEDLE (April 10, 2000)
  • K000845 — MODIFICATION TO JMS A.V. FISTULA NEEDLE SET (April 10, 2000)
  • K991904 — MODIFICATION OF JMS NEEDLES AND JMS SYRINGES (August 31, 1999)
  • K990470 — JMS A. V. FISTULA NEEDLE SET (August 30, 1999)
  • K990510 — JMS APHERESIS NEEDLE (August 30, 1999)
  • K983707 — JMS DIALYZER PRIMING SET (January 8, 1999)
  • K974902 — JMS APHERESIS NEEDLE (March 30, 1998)

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