DISPOSABLE, AMBULATORY, INFUSION PUMPS— 510(k) K940406

Name: FDA 510(k) clearance K940406
Creator: U.S. Food and Drug Administration
Published: 1994-09-02

Substantially Equivalent - Subject to Tracking Reg.

Vlv Associates, Inc.

FDA 510(k) clearance K940406 for DISPOSABLE, AMBULATORY, INFUSION PUMPS, Substantially Equivalent - Subject to Tracking Reg. on 1994-09-02. Applicant: Vlv Associates, Inc.. Device class: 2.

Clearance details

Applicant: Vlv Associates, Inc.
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1994-01-27
Decision date: 1994-09-02
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: East Hanover, NJ, US

Download summary PDF View on FDA.gov ↗

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K953791 — VLV SA EF INFUSION PORT1995-10-30
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Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.