# K993305: Transluminal Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Apr 10, 2000 after 189 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.
16 later devices descend from it; 1 cites it directly.
0 of 17 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) Ultra-thin Diamond™ Balloon Dilatation Catheter: named in the summary without a submission number
- (no number) Courier ST™ Balloon Dilatation Catheter: named in the summary without a submission number

## Most influential descendants
- K103751: Mustang Balloon Dilatation Catheters (2011), 15 descendants of its own
- K113681: Gladiator Pta Balloon Dilation Catheter (2012), 2 descendants of its own
- K201170: Athletis PTA Balloon Dilatation Catheter (2020), 1 descendant of its own
- K160256: Polux , Minerva and Atropos PTA Balloon Dilatation Catheter (2016), 1 descendant of its own
- K132810: Gladiator Elite Pta Balloon Dilatation Catheter (2014), 1 descendant of its own

## Indications for use
The Semi-Compliant 35 Balloon Dilitation Catheter is indicated for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K993305
Methodology: https://510kreport.com/methodology