IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10— 510(k) K002770

Substantially Equivalent

Hdc Corp.

FDA 510(k) clearance K002770 for IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10, Substantially Equivalent on 2000-09-26. Applicant: Hdc Corp..

Clearance details

Applicant: Hdc Corp.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 2000-09-06
Decision date: 2000-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

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Adverse events under product code LJT

product code LJT

Death: 234
Injury: 6,468
Malfunction: 5,326
Other: 2
Total: 12,030

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.