# K992880: P.a.S. Port Elite Implantable Venous Access System

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Oct 19, 1999 after 53 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
Longest line of descent: 1 generation back to K875276 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K875276: Port-a-Cath (R) Implantable Drug Delivery System, Pharmacia Deltec, Inc. (1988) Summary page 2.
- (no number) M.R.I.® Low Profile Implanted Port: named in the summary without a submission number

## Recalls of this device
- Sep 27, 2006 · Not classified · Z-0067-2007: 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-0806-06: 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

## Indications for use
A P.A.S. PORT® system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Source page: https://510kreport.com/device/K992880
Methodology: https://510kreport.com/methodology