# K942024: Port-a-Cath Low Profile Implantable Venous Access System

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia Deltec, Inc.
- Decided: Jul 26, 1994 after 91 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 5 cite it directly.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962695: Port-a-Cath II Venous Implantable Access Systems Preconnected with Polyurethane Catheter (1996), 19 descendants of its own
- K070116: Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle (2007), 18 descendants of its own
- 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
- K992697: Port-a-Cath II Trans-Arterial Percutaneous System (1999), 3 descendants of its own

## Recalls of this device
- Sep 27, 2006 · Not classified · Z-0065-2007: Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was ori
- Sep 27, 2006 · Not classified · Z-0064-2007: Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was ori
- Sep 27, 2006 · Not classified · Z-0066-2007: Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was ori
- Mar 29, 2006 · Not classified · Z-0802-06: One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT syste
- Mar 29, 2006 · Not classified · Z-0804-06: One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT syste
- Mar 29, 2006 · Not classified · Z-0803-06: One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT syste
- Mar 29, 2006 · Not classified · Z-0805-06: One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT syste
- Nov 11, 2004 · Not classified · Z-0442-05: The catheter became disconnected from the port while implanted in the patient.

Source page: https://510kreport.com/device/K942024
Methodology: https://510kreport.com/methodology