# K071309: Blue Max Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 13, 2007 after 65 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 K000570 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000570: Blue Max Balloon Dilatation Catheter, Maxforce Balloon Catheter, XXL Balloon Dilatation Cathater, Symmetry Balloon Dila, Boston Scientific Corp (2000) Summary page 1.

## Recalls of this device
- Feb 18, 2010 · Not classified · Z-1211-2010: Boston Scientific Corporation is conducting a Medical Device Recall Removal of specific lots/batches of the Blue Max and Ultrathin Diamond Balloon Dilatation Catheters. Boston Scientific has determine

## Indications for use
Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of the Iliac, Femoral and Renal Arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K071309
Methodology: https://510kreport.com/methodology