I.V. EXTENDER SET— 510(k) K911451

Name: FDA 510(k) clearance K911451
Creator: U.S. Food and Drug Administration
Published: 1991-06-06

Substantially Equivalent

Filtertek, Inc.

FDA 510(k) clearance K911451 for I.V. EXTENDER SET, Substantially Equivalent on 1991-06-06. Applicant: Filtertek, Inc.. Device class: 2.

Clearance details

Applicant: Filtertek, Inc.
Product code: Code FPB
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1991-04-03
Decision date: 1991-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hebron, IL, US

Download summary PDF View on FDA.gov ↗

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K914792 — PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET1992-01-15
K912848 — I.V. FILTER EXTENSION SET1991-11-29
K912394 — TRANSDUCER PROTECTOR1991-08-30

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.