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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 Aug 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 2 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 4, 1980
Date Received
Jul 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
510(k)

Other clearances by Bellco Artifidial Organ Spec., Inc.

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

Other clearances for product code FIE

  • K253469 — Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM)… (Aug 6, 2026)
  • K251877 — JMS CAVEO A.V. Fistula Needle Set (Aug 15, 2025)
  • K213015 — DORA Disposable A.V. Fistula Needle Sets (Apr 8, 2022)
  • K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol… (May 17, 2018)
  • K163025 — DORA Disposable A.V. Fistula Needle Sets (Jul 20, 2017)
  • K151017 — JMS Harmony A.V. Fistula Needle Set (May 13, 2015)
  • K131950 — ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET (Jan 16, 2015)
  • K142564 — JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle… (Dec 23, 2014)
  • K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE… (Sep 11, 2014)
  • K112734 — APLAN A.V. FISTULA NEEDLE SET (Apr 24, 2012)

FDA data resources

Source: FDA 510(k) database entry for K801632. Report a data issue: hello@regdatalab.com.