INJECTION PORT II --- FOR INTERMITTENT INJECTION— 510(k) K896291

Substantially Equivalent

The Medi-Dose Group

FDA 510(k) clearance K896291 for INJECTION PORT II --- FOR INTERMITTENT INJECTION, Substantially Equivalent on 1989-12-01. Applicant: The Medi-Dose Group.

Clearance details

Applicant: The Medi-Dose Group
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1989-10-31
Decision date: 1989-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Feasterville, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.