SMARTSITE ACCESS PIN— 510(k) K970485

Substantially Equivalent

Ivac Medical Systems

FDA 510(k) clearance K970485 for SMARTSITE ACCESS PIN, Substantially Equivalent on 1997-04-21. Applicant: Ivac Medical Systems.

Clearance details

Applicant: Ivac Medical Systems
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1997-02-10
Decision date: 1997-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.