K122937

Substantially Equivalent

SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)

Applicant: Cook, Inc.
Product code: DQO
Advisory panel: Cardiovascular
Date received: 2012-09-24
Decision date: 2012-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, IN, US

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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.