# K073472: Vaccess Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 9, 2008 after 29 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K014212 (2002). 1 ancestor in all.
16 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014212: Bard Conquest Pta Balloon Dilatation Catheter, C.R. Bard, Inc. (2002) Summary page 1.

## Most influential descendants
- K102645: Willow/Elm Pta Balloon Dilatation Catheter (2010), 6 descendants of its own
- K101047: Pta-Duo Pta Balloon Catheter (2010), 5 descendants of its own
- K113769: Gpscath Ballon Dilatation Catheter (2012), 4 descendants of its own
- K130397: Arrow Gpscath Balloon Dilatation Catheter (2013), 3 descendants of its own
- K171251: 014 Hydrophilic Coated PTA Balloon Dilatation Catheter (2017), 2 descendants of its own

## Recalls of this device
- May 28, 2013 · Class II · Z-1533-2013: Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically, the balloon si

## Indications for use
The VaccessTM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K073472
Methodology: https://510kreport.com/methodology