# K972357: Blue Max - 20 Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 19, 1997 after 147 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.
31 later devices descend from it; 1 cites it directly.
1 of 32 devices in its family (counting itself) has 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) Blue Max Balloon Dilatation Catheter: named in the summary without a submission number
- (no number) Ultra-thin Diamond Balloon Dilatation Catheter: named in the summary without a submission number

## Most influential descendants
- K041630: Orbital Atherectomy System for Treatment of a-V Shunt Stenosis (2005), 30 descendants of its own
- K071427: Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt Stenosis (2007), 28 descendants of its own
- K071350: Diamondback 360 Degree Orbital Atherectomy System (2007), 28 descendants of its own
- K072748: Modification to: Diamondback 360 Orbital Atherectomy System (2007), 26 descendants of its own
- K081944: Modification to Diamondback 360 Degree Orbital Atherectomy System (2008), 25 descendants of its own

## Indications for use
Blue Max 20 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/K972357
Methodology: https://510kreport.com/methodology