SAMUELS - MICRO -SCLER CATHETER— 510(k) K891164

Substantially Equivalent

Polyval, Inc.

FDA 510(k) clearance K891164 for SAMUELS - MICRO -SCLER CATHETER, Substantially Equivalent on 1989-06-23. Applicant: Polyval, Inc..

Clearance details

Applicant: Polyval, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1989-03-06
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Gabriel, 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.