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510(k) K844343

TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE by Top Surgical Manufacturers Co. — Product Code FIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1985
Date Received
November 9, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Fistula
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Top Surgical Manufacturers Co.

  • K843415 — TOP HYPODERMIC SYRINGE LUER LOCK (December 7, 1984)
  • K843313 — TOP DISPOSABLE SPINAL NEEDLE (September 19, 1984)
  • K843414 — TOP HYPODERMIC SYRINGE PISTON (September 7, 1984)
  • K841119 — TOPS DISPOS. INFUSION SET/HEMODIALYSIS (April 20, 1984)
  • K841025 — TOP DISPOSABLE INFUSION SET (March 30, 1984)
  • K832624 — TOP VENULA I.V. CATHETER SET (November 21, 1983)
  • K832625 — TOP THREE WAY STOPCOCK (October 19, 1983)
  • K832621 — TOP DISPOSABLE PLASTIC SYRINGES (October 14, 1983)
  • K832623 — TOP DISPOS. INFUSION SET/HEMODIALY (October 14, 1983)
  • K832626 — TOP STERILE DISPOS. HYPODERMIC NEEDLES (October 14, 1983)

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  • K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposa (May 17, 2018)
  • K163025 — DORA Disposable A.V. Fistula Needle Sets (July 20, 2017)
  • K151017 — JMS Harmony A.V. Fistula Needle Set (May 13, 2015)
  • K131950 — ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET (January 16, 2015)
  • K142564 — JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle S (December 23, 2014)
  • K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECT (September 11, 2014)
  • K112734 — APLAN A.V. FISTULA NEEDLE SET (April 24, 2012)
  • K112178 — JMS APHERESIS NEEDLE SET WINGEATER(R) V2 (October 27, 2011)