# K020379: PPD Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Telemed Systems, Inc.
- Decided: May 6, 2002 after 90 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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) GI balloon dilatation catheters marketed by TeleMed Systems: named in the summary without a submission number
- (no number) GI balloon dilatation catheters marketed by Boston Scientific: named in the summary without a submission number

## Indications for use
The TeleMed Systems PPD™ Balloon Dilatation Catheter is indicated for use in dilatation of gastrointestinal strictures of various etiologies (inflammatory, neoplastic, congenital, anastomotic) involving the esophagus, pylorus, biliary tract, sphincter of Oddi and colon.

Source page: https://510kreport.com/device/K020379
Methodology: https://510kreport.com/methodology