The following data is part of a premarket notification filed by Shockwave Medical, Inc. with the FDA for Shockwave M5 Peripheral Intravascular Lithotripsy (ivl) Catheter, Lntravascular Lithotripsy (ivl) Generator And Connector Cable, Intravascular Lithotripsy (ivl) Connector Cable.
| Device ID | K180958 |
| 510k Number | K180958 |
| Device Name: | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, Lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable |
| Classification | Percutaneous Catheter, Ultrasound |
| Applicant | Shockwave Medical, Inc. 48501 Warm Springs Blvd, Suite 108 Fremont, CA 94539 |
| Contact | Cindy Morrow |
| Correspondent | Cindy Morrow 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 | 2018-04-12 |
| Decision Date | 2018-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195451000195 | K180958 | 000 |
| 00195451000188 | K180958 | 000 |
| 00195451000171 | K180958 | 000 |
| 00195451000164 | K180958 | 000 |
| 00195451000157 | K180958 | 000 |
| 00195451000140 | K180958 | 000 |
| 00195451000133 | K180958 | 000 |
| 00195451000126 | K180958 | 000 |