# K953647: MS Classique Balloon Catheter W/Hydropass Coating

- Pathway: 510(k) (Traditional)
- Applicant: Meadox Medicals, Div. Boston Scientific Corp.
- Decided: May 16, 1997 after 651 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
Longest line of descent: 1 generation back to K943298 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942293: MS Classique Balloon Catheter, Meadox Medicals, Div. Boston Scientific Corp. (1994) Summary page 1.
- K943298: MS Classique Balloon Catheter, Meadox Medicals, Div. Boston Scientific Corp. (1994) Summary page 1.

Source page: https://510kreport.com/device/K953647
Methodology: https://510kreport.com/methodology