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510(k) K915174

JMS APHERESIS NEEDLE by Jms Co., Ltd. — Product Code FIE

K915174 is an FDA 510(k) premarket notification submitted by Jms Co., Ltd. for the device "JMS APHERESIS NEEDLE". The FDA issued a decision of Substantially Equivalent on Mar 2, 1993. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Jms Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 2, 1993
Date Received
Nov 15, 1991
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 Jms Co., Ltd.

  • K002352 — JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE (Sep 6, 2001)
  • K002394 — JMS APHERESIS NEEDLE SET ACCORDION TYPE (Sep 5, 2001)
  • K010406 — JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G (Jun 20, 2001)
  • K010410 — JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G (Jun 20, 2001)
  • K000845 — MODIFICATION TO JMS A.V. FISTULA NEEDLE SET (Apr 10, 2000)
  • K000843 — MODIFICATION TO JMS APHERESIS NEEDLE (Apr 10, 2000)
  • K991904 — MODIFICATION OF JMS NEEDLES AND JMS SYRINGES (Aug 31, 1999)
  • K990470 — JMS A. V. FISTULA NEEDLE SET (Aug 30, 1999)
  • K990510 — JMS APHERESIS NEEDLE (Aug 30, 1999)
  • K983707 — JMS DIALYZER PRIMING SET (Jan 8, 1999)

Other clearances for product code FIE

  • K253469 — Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritu (Aug 6, 2026)
  • K251877 — JMS CAVEO A.V. Fistula Needle Set (Aug 15, 2025)
  • K213015 — DORA Disposable A.V. Fistula Needle Sets (Apr 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 (Jul 20, 2017)
  • K151017 — JMS Harmony A.V. Fistula Needle Set (May 13, 2015)
  • K131950 — ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET (Jan 16, 2015)
  • K142564 — JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle S (Dec 23, 2014)
  • K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECT (Sep 11, 2014)
  • K112734 — APLAN A.V. FISTULA NEEDLE SET (Apr 24, 2012)

FDA data resources