# K963397: Ultra-Thin Diamond Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 25, 1996 after 88 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- 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 -- PEMT-5 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

## Recalls of this device
- Feb 18, 2010 · Not classified · Z-1210-2010: Boston Scientific Corporation is conducting a Medical Device Recall Removal of specific lots/batches of the Blue Max and Ultrathin Diamond Balloon Dilatation Catheters. Boston Scientific has determine

## Indications for use
The Diamond™ 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 fistulae. In addition, certain sizes of the Diamond balloon catheter are indicated for stent deployment / optimization of the J&J Palmaz Biliary Stent into the biliary ducts.

Source page: https://510kreport.com/device/K963397
Methodology: https://510kreport.com/methodology