DeviceClearance

CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0— 510(k) K130394

Substantially Equivalent

Smiths Medical Asd, Inc.

FDA 510(k) clearance K130394 for CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0, Substantially Equivalent on 2013-12-09. Applicant: Smiths Medical Asd, Inc.. Device class: 2.

Clearance details

Applicant
Smiths Medical Asd, Inc.
Product code
Code MEA
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Paul, MN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code MEA

view all

More clearances from Smiths Medical Asd, Inc.

view all

Adverse events under product code MEA

product code MEA
Death
19
Malfunction
25,089
Total
25,108

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

Recalls naming K130394

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130394.

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