# K965183: Vantage Peripheral Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Apr 24, 1997 after 121 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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 K920547 (1992). 2 ancestors in all.
13 later devices descend from it; 1 cites it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934433: Vantage Dialtaion Catheter, Peripheral Systems Group (1993) Summary page 1.
- K920547: Ultra-Thin, Boston Scientific Corp (1992) Summary page 1.

## Most influential descendants
- K983830: Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter (1999), 12 descendants of its own
- K022212: Portex Percutaneous Dilatational Tracheostomy Kits (2003), 10 descendants of its own
- K040014: Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9MM Tubes Only (2004), 6 descendants of its own
- K041348: Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra (2004), 5 descendants of its own
- K133597: Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray (2014), 2 descendants of its own

## Indications for use
The VANTAGE™ Peripheral Dilatation Catheter is intended for use in Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Popliteal arteries. The VANTAGE™ Peripheral Dilatation Catheter is not intended for use in the coronary arteries or in neurovasculature.

Source page: https://510kreport.com/device/K965183
Methodology: https://510kreport.com/methodology