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510(k) K945850

BRAUN DIACAN(R) FISTULA NEEDLES by B. Braun of America, Inc. — Product Code FIE

K945850 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "BRAUN DIACAN(R) FISTULA NEEDLES". The FDA issued a decision of Substantially Equivalent on October 6, 1995. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1995
Date Received
November 30, 1994
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 B. Braun of America, Inc.

  • K993024 — CELSITE IMPLANTABLE PORT WITH VALVED CATHETER (March 13, 2000)
  • K983794 — CHEMO MINI SPIKE PLUS (March 23, 1999)
  • K946170 — COMFORT-Q SUBCUTANEOUS INJECTION SETS (November 3, 1995)
  • K942988 — FILTERED EXTENSION SETS (July 14, 1995)
  • K945752 — CELSITE(TM) BRACHIAL VENOUS PORT (May 31, 1995)
  • K945551 — CELSITE(TM) DUAL VENOUS SYSTEM (April 21, 1995)
  • K943770 — LOW VOLUME MULTIPORT (April 10, 1995)
  • K950982 — B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE (April 4, 1995)
  • K950184 — B. BRAUN IV START KITS (March 15, 1995)
  • K943181 — DISPENSING PIN WITH ONE-WAY VALVE (September 29, 1994)

Other clearances for product code FIE

  • K253469 — Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritu (August 6, 2026)
  • 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)

FDA data resources