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510(k) K131950

ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET by Summit International Medical Technologies, Inc. — Product Code FIE

K131950 is an FDA 510(k) premarket notification submitted by Summit International Medical Technologies, Inc. for the device "ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET". The FDA issued a decision of Substantially Equivalent on January 16, 2015. 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
January 16, 2015
Date Received
June 27, 2013
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)
  • 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)
  • K111948 — WINGEATER V2 (October 24, 2011)

FDA data resources