BIOSPHERE MEDICAL INFUSION CATHETER— 510(k) K003105

Substantially Equivalent

Biosphere Medical

FDA 510(k) clearance K003105 for BIOSPHERE MEDICAL INFUSION CATHETER, Substantially Equivalent on 2001-05-22. Applicant: Biosphere Medical.

Clearance details

Applicant: Biosphere Medical
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2000-10-04
Decision date: 2001-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.