# K974683: Naviport Deflectable Tip Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cardima, Inc.
- Decided: Jun 22, 1999 after 553 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931794 (1994). 2 ancestors in all.
119 later devices descend from it; 6 cite it directly.
8 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931794: Marinr Series EP Diagnostic Catheters, Medtronic Cardiorhythm (1994) Summary page 2.
- K955651: Medtronic Sherpa Guiding Catheter, Medtronics Interventional Vascular (1996) Summary page 2.

## Most influential descendants
- K013517: 10600 Deflectable Catheter System, Model 10600 (2002), 80 descendants of its own
- K032312: Attain 6226DEF Deflectable Catheter Delivery System (2003), 37 descendants of its own
- K012749: Biocardia Universal Deflectable Guide Catheter, Model 000664 (2002), 37 descendants of its own
- K033989: Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 (2004), 35 descendants of its own
- K040922: Venture Wire Control Catheter (2004), 31 descendants of its own

## Indications for use
The NAVIPORT deflectable guiding catheter is intended to serve as a conduit for access into the chambers and coronary vasculature of the heart.

Source page: https://510kreport.com/device/K974683
Methodology: https://510kreport.com/methodology