DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH— 510(k) K080415

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K080415 for DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH, Substantially Equivalent on 2008-03-07. Applicant: Terumo Medical Corp..

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2008-02-14
Decision date: 2008-03-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Elkton, MD, US

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.