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510(k) K093985

NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE by Nipro Medical Corp. — Product Code FIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2010
Date Received
December 24, 2009
Clearance Type
Special
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 Nipro Medical Corp.

  • K081210 — NIPRO SAFETOUCH HUBER INFUSTION SET (October 21, 2008)
  • K072024 — NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A21 (October 4, 2007)
  • K063368 — NIPRO BIOHOLE NEEDLE (February 5, 2007)
  • K063721 — NIPRO SAFETOUCH II GAMMA (January 12, 2007)
  • K052474 — NIPRO HYPODERMIC NEEDLE (November 10, 2005)
  • K051574 — NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE (August 26, 2005)
  • K041779 — NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L (September 21, 2004)
  • K032777 — MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE (November 14, 2003)
  • K030683 — NIPRO DISPOSABLE SYRINGES (October 31, 2003)
  • K022756 — NIPRO BIO-FLEX CATHETER (October 18, 2002)

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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)