The following data is part of a premarket notification filed by Shockwave Medical, Inc. with the FDA for Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator And Connector Cable, Lithoplasty Connector Cable.
| Device ID | K161384 |
| 510k Number | K161384 |
| Device Name: | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator And Connector Cable, Lithoplasty Connector Cable |
| Classification | Percutaneous Catheter, Ultrasound |
| Applicant | Shockwave Medical, Inc. 48501 Warm Springs Blvd, Suite 108 Fremont, CA 94539 |
| Contact | Nora Hadding |
| Correspondent | Nora Hadding Shockwave Medical, Inc. 48501 Warm Springs Blvd, Suite 108 Fremont, CA 94539 |
| Product Code | PPN |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-19 |
| Decision Date | 2016-09-14 |
| Summary: | summary |