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510(k) K023162

FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS by Fresenius Medical Care — Product Code FIE

K023162 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care for the device "FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS". The FDA issued a decision of Substantially Equivalent on March 20, 2003. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Fresenius Medical Care has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2003
Date Received
September 23, 2002
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 Fresenius Medical Care

  • K231534 — 5008X Hemodialysis System (February 2, 2024)
  • K141997 — CRIT-LINE IV SYSTEM (April 1, 2015)
  • K111639 — FRESENIUS 2008T HEMODIALYSIS MACHINE (October 21, 2011)
  • K030497 — FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30X (May 20, 2003)
  • K022536 — \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RES (October 30, 2002)
  • K994267 — FRESENIUS 2008K (March 16, 2000)

Other clearances for product code FIE

  • K251877 — JMS CAVEO A.V. Fistula Needle Set (August 15, 2025)
  • K213015 — DORA Disposable A.V. Fistula Needle Sets (April 8, 2022)
  • 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)

FDA data resources