# K093414: Port-a-Cath Power P.a.C. Implantable Venous Access Systems

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Mar 1, 2010 after 119 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070116: Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle, Smiths Medical MD, Inc. (2007) Summary page 2.
- (no number) PORT-A-CATH II POWER P.A.C. Implantable Venous Access Systems: named in the summary without a submission number

## Recalls of this device
- Dec 4, 2017 · Class II · Z-1074-2018: Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. T

## Indications for use
The PORT-A-CATH II 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 PORT-A-CATH II POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec. The PORT-A-CATH 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 PORT-A-CATH POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec. The P.A.S. Port T2 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 P.A.S. Port POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec.

Source page: https://510kreport.com/device/K093414
Methodology: https://510kreport.com/methodology