MODIFICATION TO DISPOSABLE INFUSION PUMP KIT— 510(k) K071735

Name: FDA 510(k) clearance K071735
Creator: U.S. Food and Drug Administration
Published: 2007-07-19

Substantially Equivalent

Symbios Medical Products, LLC

FDA 510(k) clearance K071735 for MODIFICATION TO DISPOSABLE INFUSION PUMP KIT, Substantially Equivalent on 2007-07-19. Applicant: Symbios Medical Products, LLC. Device class: 2.

Clearance details

Applicant: Symbios Medical Products, LLC
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2007-06-26
Decision date: 2007-07-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K151650 — SMARTez elastomeric infusion pump2016-04-04

More clearances from Symbios Medical Products, LLC

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K072921 — DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM2007-11-26
K051474 — SYMBIOS DISPOSABLE INFUSION PUMP KIT2005-07-01

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.