BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP— 510(k) K983372

Substantially Equivalent

Sunscope Intl., Inc.

FDA 510(k) clearance K983372 for BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP, Substantially Equivalent on 1999-02-05. Applicant: Sunscope Intl., Inc..

Clearance details

Applicant: Sunscope Intl., Inc.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1998-09-24
Decision date: 1999-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.