# K970379: Channel Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: May 1, 1997 after 87 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.
No later device cites it as a predicate yet.
0 of 1 device 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) BSC -- Courier Balloon Dilatation Catheter: named in the summary without a submission number
- (no number) BSC -- Ultra-thin Diamond Balloon Catheter: named in the summary without a submission number
- (no number) BSC -- Katzen Thrombolysis Guidewire: named in the summary without a submission number
- (no number) LocalMed Inc. - Kaplan Simpson InfusSleeve Catheter: named in the summary without a submission number

## Indications for use
The proposed Channel™ Balloon catheter is an over-the-wire balloon catheter with four lumens indicated 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. A secondary function is the controlled selective regional infusion of contrast or therapeutic agents into the peripheral vasculature.

Source page: https://510kreport.com/device/K970379
Methodology: https://510kreport.com/methodology