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 | K163306 |
510k Number | K163306 |
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 | Plessy Paul |
Correspondent | Plessy Paul 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-23 |
Decision Date | 2016-12-22 |
Summary: | summary |