Panels › Cardiovascular › Product code PPN · Class 2
Percutaneous Catheter, Ultrasound
Regulation 870.1250
2510(k)s in 12 months (14 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PPN
| Company | 510(k)s | Recalls |
|---|---|---|
| Shockwave Medical, Inc. | 12 | 1 |
| Bolt Medical, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2018 | Shockwave Medical, Inc. The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femor Terminated |
PPN | K180454 |
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