PT HEPARIN ADSORBENT— 510(k) K870771

Substantially Equivalent

Probe-Tek, Inc.

FDA 510(k) clearance K870771 for PT HEPARIN ADSORBENT, Substantially Equivalent on 1987-04-23. Applicant: Probe-Tek, Inc..

Clearance details

Applicant: Probe-Tek, Inc.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1987-02-26
Decision date: 1987-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansing, MI, US

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Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

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.