ASPIRATION PUMP, MODEL IMD-020— 510(k) K041405

Substantially Equivalent

Industrial & Medical Design, Inc.

FDA 510(k) clearance K041405 for ASPIRATION PUMP, MODEL IMD-020, Substantially Equivalent on 2004-09-02. Applicant: Industrial & Medical Design, Inc.. Device class: 2.

Clearance details

Applicant
Industrial & Medical Design, Inc.
Product code
Code BTA
Device class
Class 2
Regulation
21 CFR 878.4780
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Monterey Park, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code BTA

product code BTA
Death
5
Total
5

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 →

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