HPD TUBING CONNECTORS— 510(k) K895795

Substantially Equivalent

Hpd Medical, Inc.

FDA 510(k) clearance K895795 for HPD TUBING CONNECTORS, Substantially Equivalent on 1990-01-26. Applicant: Hpd Medical, Inc.. Device class: 2.

Clearance details

Applicant
Hpd Medical, Inc.
Product code
Code DTL
Device class
Class 2
Regulation
21 CFR 870.4290
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Clemente, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DTL

product code DTL
Malfunction
770
Total
770

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.