PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP— 510(k) K121032

Substantially Equivalent

Hospira, Inc.

FDA 510(k) clearance K121032 for PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP, Substantially Equivalent on 2012-06-21. Applicant: Hospira, Inc..

Clearance details

Applicant: Hospira, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2012-04-05
Decision date: 2012-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Lake Forest, IL, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.