GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500— 510(k) K022880

Substantially Equivalent

Guidant Corp.

FDA 510(k) clearance K022880 for GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500, Substantially Equivalent on 2002-09-13. Applicant: Guidant Corp..

Clearance details

Applicant: Guidant Corp.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2002-08-30
Decision date: 2002-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CA, US

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Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.