# K991897: Catheter Innovations Implantable Port

- Pathway: 510(k) (Traditional)
- Applicant: Catheter Innovations, Inc.
- Decided: Oct 21, 1999 after 139 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K873213 (1987). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880571: Cath-Tech Port Implantable Vascular Access System, Catheter Technology Corp. (1988) Summary page 1.
- K873213: Hickman Plastic Subcutaneous Port, C.R. Bard, Inc. (1987) Summary page 1.

## Most influential descendants
- K993860: Catheter Innovations Implantable Port (1999), 0 descendants of its own

## Recalls of this device
- Oct 28, 2005 · Not classified · Z-0344-06: Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
- Oct 28, 2005 · Not classified · Z-0343-06: Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
- Jul 22, 2005 · Not classified · Z-1516-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1512-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1513-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1515-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1514-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1517-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Mar 29, 2004 · Not classified · Z-0847-04: Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.

## Indications for use
The Catheter Innovations Implantable Port is designed for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.

Source page: https://510kreport.com/device/K991897
Methodology: https://510kreport.com/methodology