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510(k) K801632

THE BELLCO FISTULA NEEDLES by Bellco Artifidial Organ Spec., Inc. — Product Code FIE

K801632 is an FDA 510(k) premarket notification submitted by Bellco Artifidial Organ Spec., Inc. for the device "THE BELLCO FISTULA NEEDLES". The FDA issued a decision of Substantially Equivalent on August 4, 1980. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Bellco Artifidial Organ Spec., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1980
Date Received
July 15, 1980
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 Bellco Artifidial Organ Spec., Inc.

  • K801633 — THE BRAVO NEW PARALLEL FLOW DIALYZER (December 18, 1980)
  • K801634 — THE VITA 2 DISPOSABLE DIALYZER (December 17, 1980)

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