CATHETERS, H-H ATRIAL AND PERITONEAL— 510(k) K781768

Name: FDA 510(k) clearance K781768
Creator: U.S. Food and Drug Administration
Published: 1978-11-14

Substantially Equivalent

Holter-Hausner Intl.

FDA 510(k) clearance K781768 for CATHETERS, H-H ATRIAL AND PERITONEAL, Substantially Equivalent on 1978-11-14. Applicant: Holter-Hausner Intl.. Device class: 2.

Clearance details

Applicant: Holter-Hausner Intl.
Product code: Code JXG
Device class: Class 2
Regulation: 21 CFR 882.5550
Advisory panel: Neurology
Date received: 1978-10-16
Decision date: 1978-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC1987-09-28
K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC1987-09-28
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Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.