IV FILTER EXTENSION SET— 510(k) K860803

Name: FDA 510(k) clearance K860803
Creator: U.S. Food and Drug Administration
Published: 1986-04-09

Substantially Equivalent

Med Fusion Systems, Inc.

FDA 510(k) clearance K860803 for IV FILTER EXTENSION SET, Substantially Equivalent on 1986-04-09. Applicant: Med Fusion Systems, Inc.. Device class: 2.

Clearance details

Applicant: Med Fusion Systems, Inc.
Product code: Code FPB
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1986-03-04
Decision date: 1986-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FPB

view all

K261403 — Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter2026-08-31
K233277 — Filter Needle for Single Use2024-05-10
K143583 — Cathivex ¿GV filter units2015-08-11
K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER2011-12-08
K021293 — ARTERIA BLOOD FILTER2002-08-22

More clearances from Med Fusion Systems, Inc.

view all

K873961 — INFUMED 300 AMBULATORY INFUSION PUMP1987-12-29
K870524 — AMBULATORY INFUSION PUMP DRUG RESERVOIR1987-05-06
K870907 — INTRODUCER, PERCUTANEOUS1987-04-09
K864407 — REFILLABLE SYRINGE1987-01-20
K863814 — BAG SPIKE EXTENSION SET1986-10-14

Adverse events under product code FPB

product code FPB

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.