# K960501: Ultra-Thin Diamond Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Apr 9, 1996 after 67 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.
8 later devices descend from it; 3 cite it directly.
0 of 9 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) Blue Max Balloon Dilatation Catheter: named in the summary without a submission number
- (no number) Ultra-thin™ Balloon Catheter: named in the summary without a submission number
- (no number) Symmetry™ Small Vessel Balloon Dilatation Catheter: named in the summary without a submission number
- (no number) Courier™ Balloon Dilatation Catheter: named in the summary without a submission number

## Most influential descendants
- K040155: Peripheral Cutting Balloon (2004), 6 descendants of its own
- K051254: Peripheral Cutting Balloon (2005), 5 descendants of its own
- K041993: 2 CM Peripheral Cutting Baloon (2004), 5 descendants of its own
- K052038: Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System (2005), 4 descendants of its own
- K062387: Small Peripheral Cutting Ballon, Monorail Delivery System (2006), 3 descendants of its own

## Indications for use
The Diamond™ Vessel Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistalae.

Source page: https://510kreport.com/device/K960501
Methodology: https://510kreport.com/methodology