INTRAVENOUS FILTER W/FLASH BULB— 510(k) K771827

Name: FDA 510(k) clearance K771827
Creator: U.S. Food and Drug Administration
Published: 1977-10-13

Substantially Equivalent

Jelco Laboratories

FDA 510(k) clearance K771827 for INTRAVENOUS FILTER W/FLASH BULB, Substantially Equivalent on 1977-10-13. Applicant: Jelco Laboratories. Device class: 2.

Clearance details

Applicant: Jelco Laboratories
Product code: Code FPB
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1977-09-19
Decision date: 1977-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Jelco Laboratories

view all

K791918 — JELCO WINGED INTRAVASCULAR CATHETER1979-10-02
K791372 — JELCO & KVO CATHETER PLACEMENT UNIT1979-09-12
K790967 — CATHETER METAL HUB/RADIOPAQUE1979-06-27
K790968 — CATHETER METAL HUB/NONRADIOPAQUE1979-06-11
K790471 — JELCO* DISC FILTER-0.2 MICRON1979-04-30

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.