HARBORIN CENTRAL VENOUS CATHETER— 510(k) K884628

Substantially Equivalent

Harbor Medical Devices, Inc.

FDA 510(k) clearance K884628 for HARBORIN CENTRAL VENOUS CATHETER, Substantially Equivalent on 1989-05-15. Applicant: Harbor Medical Devices, Inc..

Clearance details

Applicant: Harbor Medical Devices, Inc.
Product code: Code DQR
Advisory panel: Cardiovascular
Date received: 1988-11-07
Decision date: 1989-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

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Adverse events under product code DQR

product code DQR

Death: 2
Total: 2

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.