# K960517: Bard Tru-Trac Peripheral Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 9, 1996 after 64 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
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medi-Tech® Ultra-Thin™ Balloon Dilatation Catheter: named in the summary without a submission number

## 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
Recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Any use of this product for procedures other than those indicated is not recommended.

Source page: https://510kreport.com/device/K960517
Methodology: https://510kreport.com/methodology