# K871132: Pharmacia Deltec Subclavian Introducers

- Pathway: 510(k) (Traditional)
- Applicant: Deltec Systems, Inc.
- Decided: Apr 20, 1987 after 31 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have 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
- K112407: Smith Medical Peel-Away Sheath Introducers (2012), 0 descendants of its own

## Recalls of this device
- Sep 10, 2013 · Class II · Z-2268-2013: Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small numbe
- 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-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-0800-06: 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-0801-06: 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-0807-06: 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

Source page: https://510kreport.com/device/K871132
Methodology: https://510kreport.com/methodology