HARBOR CENTRAL VENOUS CATHETER— 510(k) K881884

Substantially Equivalent

Harbor Medical Devices, Inc.

FDA 510(k) clearance K881884 for HARBOR CENTRAL VENOUS CATHETER, Substantially Equivalent on 1988-07-28. Applicant: Harbor Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant
Harbor Medical Devices, Inc.
Product code
Code DQR
Device class
Class 2
Regulation
21 CFR 870.1300
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boston, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DQR

product code DQR
Death
2
Total
2

Source: openFDA MAUDE database, through . 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.