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510(k) K112734

APLAN A.V. FISTULA NEEDLE SET by Aplan Well Enterprise Co., Ltd. — Product Code FIE

K112734 is an FDA 510(k) premarket notification submitted by Aplan Well Enterprise Co., Ltd. for the device "APLAN A.V. FISTULA NEEDLE SET". The FDA issued a decision of Substantially Equivalent on April 24, 2012. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2012
Date Received
September 20, 2011
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 for product code FIE

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  • 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)
  • K112178 — JMS APHERESIS NEEDLE SET WINGEATER(R) V2 (October 27, 2011)
  • K111948 — WINGEATER V2 (October 24, 2011)

FDA data resources