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510(k) K770864

HEMODIALYSIS FISTULA SET by Venospital, Inc. — Product Code FIE

K770864 is an FDA 510(k) premarket notification submitted by Venospital, Inc. for the device "HEMODIALYSIS FISTULA SET". The FDA issued a decision of Substantially Equivalent on June 24, 1977. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Venospital, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1977
Date Received
May 11, 1977
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 Venospital, Inc.

  • K791131 — FLU VEN TR-1 (September 4, 1979)
  • K791130 — FLU-VEN TK-2 (September 4, 1979)
  • K790424 — FLU-VEN 01510 (April 30, 1979)
  • K790077 — BIOSTIL # 3884 (April 30, 1979)
  • K781187 — INFUSION SET W/ INJECTION SITE, 23D-W (August 10, 1978)
  • K781190 — INFUSION SET, VENOTHIN 21 (August 10, 1978)
  • K781186 — INFUSION, VENOTHIN 23 (August 10, 1978)
  • K781189 — FLU VEN 0151 (August 10, 1978)
  • K781188 — INFUSION SET, VENOTHIN 25 (August 10, 1978)
  • K781185 — INFUSION SET W/ INJECTION SITE (August 10, 1978)

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