CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013— 510(k) K013523

Substantially Equivalent

Shire Biologics, Inc.

FDA 510(k) clearance K013523 for CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013, Substantially Equivalent on 2002-01-07. Applicant: Shire Biologics, Inc..

Clearance details

Applicant: Shire Biologics, Inc.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2001-10-23
Decision date: 2002-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.