Device type
Percutaneous Catheter, Ultrasound
Product code PPN · Class II · 21 CFR 870.1250 · Cardiovascular
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
Recent 510(k)s
Aug 24, 2026
K260246
SEISMIQ™ Intravascular Lithotripsy System
Bolt Medical, Inc.
- PPN
- Class II
Recent recalls
No recalls in the archive for PPN.