POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE— 510(k) K070116

Clearance details

Applicant

Smiths Medical MD, Inc.

Product code

Code LJT

Device class

Class 2

Regulation

21 CFR 880.5965

Advisory panel

General Hospital

Date received

2007-01-12

Decision date

2007-05-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

St. Paul, MN, US

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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 →