# K070116: Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical MD, Inc.
- Decided: May 23, 2007 after 131 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001901 (2000). 28 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864446: Port-a-Cath Vascular Access Systems, Pharmacia, Inc. (1987) Summary page 2.
- K875276: Port-a-Cath (R) Implantable Drug Delivery System, Pharmacia Deltec, Inc. (1988) Summary page 2.
- K932095: Port-a-Cath Dual Lumen Implantable Venous Access S, Pharmacia Deltec, Inc. (1994) Summary page 2.
- K942024: Port-a-Cath Low Profile Implantable Venous Access System, Pharmacia Deltec, Inc. (1994) Summary page 2.
- K060036: Port-a-Cath, Port-a-Cath II, Proport and P.a.S. Port Implantable Venous Access Systems with Dual Layer Catheter, Smiths Medical MD, Inc. (2006) Summary page 2.
- K932840: Port-a-Cath Implantable Vascular Access System, Pharmacia Deltec, Inc. (1994) Summary page 2.
- K962695: Port-a-Cath II Venous Implantable Access Systems Preconnected with Polyurethane Catheter, Sims Deltec, Inc. (1996) Summary page 2.
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple, C.R. Bard, Inc. (2006) Summary page 2.
- K021999: Gripper Plus Needle, Deltec, Inc. (2002) Summary page 2.

## Most influential descendants
- K073050: Safestep Max Power-Injectable Infusion Set (2008), 13 descendants of its own
- K170897: Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site (2017), 6 descendants of its own
- K230715: Promisemed Safety Huber Needle (2023), 2 descendants of its own
- K200463: Huber Needle Infusion Set, Safety Huber Needle Infusion Set (2021), 2 descendants of its own
- K153440: PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set (2016), 2 descendants of its own

## Indications for use
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. needle, the PORT-A-CATH® POWER P.A.C. implantable venous access system is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec. The PORT-A-CATH® II POWER P.A.C. implantable venous access system is 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. needle, the PORT-A-CATH® II POWER P.A.C. implantable venous access system is 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. 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 the PORT-A-CATH® POWER P.A.C. and POWER PORT-A-CATIH® II POWER P.A.C. implantable venous access systems, the GRIPPER PLUS® POWER P.A.C. needle is also indicated for power injection of contrast media into the central venous system. The maximum recommended infusion rate is 5 ml/sec. for 19 and 20 gauge needles and 3ml/sec. for 22 gauge needles.

Source page: https://510kreport.com/device/K070116
Methodology: https://510kreport.com/methodology