MODIFICATION TO SOAKER CATHETER— 510(k) K043456

Substantially Equivalent

I-Flow Corp.

FDA 510(k) clearance K043456 for MODIFICATION TO SOAKER CATHETER, Substantially Equivalent on 2005-01-11. Applicant: I-Flow Corp..

Clearance details

Applicant: I-Flow Corp.
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2004-12-15
Decision date: 2005-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Lake Forest, CA, US

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Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.