Home › Device types › PPN
Percutaneous Catheter, Ultrasound
FDA product code PPN · Class 2 · Cardiovascular
75
Registered devices
238
Adverse events
1
Recalls
13
510(k) clearances
Devices with this code
SEISMIQ™ — Bolt Medical, Inc.Lithoplasty® — Shockwave Medical, Inc.SEISMIQ™ — Bolt Medical, Inc.Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter — Shockwave Medical, Inc.Lithoplasty® — Shockwave Medical, Inc.Lithoplasty® — Shockwave Medical, Inc.SEISMIQ™ — Bolt Medical, Inc.Shockwave Medical IVL Generator and Connector Cable — Shockwave Medical, Inc.Shockwave Medical IVL Generator and Connector Cable — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter — Shockwave Medical, Inc.Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter — Shockwave Medical, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-07-18 | Shockwave Medical, Inc. | Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM). |
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