DeviceClearance

POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS— 510(k) K072657

Substantially Equivalent

Smiths Medical MD, Inc.

FDA 510(k) clearance K072657 for POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS, Substantially Equivalent on 2007-12-14. Applicant: Smiths Medical MD, Inc.. Device class: 2.

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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Paul, MN, US
Download summary PDFView on FDA.gov ↗

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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, 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 →

Recalls naming K072657

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072657.

Data sourced from openFDA. This site is unofficial and independent of the FDA.