# K072657: Power Port-a-Cath, Cath II, and P.a.S. Port T2 Power P.a.C. Implantable Venous Access Systems and Power Gripper Plus

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical MD, Inc.
- Decided: Dec 14, 2007 after 85 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Smiths Medical MD, Inc. PORT-A-CATH and PORT-A-CATH II POWER P.A.C. Implantable Venous Access Systems: named in the summary without a submission number
- (no number) Smiths Medical MD, Inc. Gripper Plus POWER P.A.C. Needle: named in the summary without a submission number
- (no number) Smiths Medical MD, Inc. P.A.S. Port T2 Implantable Venous Access System: named in the summary without a submission number
- (no number) Smiths Medical MD, Inc. PORT-A-CATH II 7 French, Dual Lumen Low Profile Implantable Venous Access System: named in the summary without a submission number
- (no number) Medcomp Power Injectable Implantable Infusion Port: named in the summary without a submission number

## Recalls of this device
- Jun 11, 2020 · Class II · Z-2499-2020: Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.
- Jul 8, 2019 · Class II · Z-0190-2020: Potential for certain GRIPPER Needles to contain an occluded or blocked needle.

## Indications for use
Smiths Medical MD, Inc. POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. When used with a GRIPPER PLUS POWER P.A.C. Safety Huber Needle or other power injectable huber needle, the Smiths Medical MD, Inc. POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec. The GRIPPER PLUS® POWER P.A.C. Safety Huber Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. When used with power injectable implantable venous access ports, the GRIPPER PLUS POWER P.A.C. Safety Huber Needle is indicated for power injection of contrast media.

Source page: https://510kreport.com/device/K072657
Methodology: https://510kreport.com/methodology