The following data is part of a premarket notification filed by Shockwave Medical, Inc. with the FDA for Shockwave Intravascular Lithotripsy (ivl) System With The Shockwave L6 Peripheral Ivl Catheter.
Device ID | K221852 |
510k Number | K221852 |
Device Name: | Shockwave Intravascular Lithotripsy (IVL) System With The Shockwave L6 Peripheral IVL Catheter |
Classification | Percutaneous Catheter, Ultrasound |
Applicant | Shockwave Medical, Inc. 5403 Betsy Ross Dr Santa Clara, CA 95054 |
Contact | Danica Van |
Correspondent | Danica Van Shockwave Medical, Inc. 5403 Betsy Ross Dr Santa Clara, CA 95054 |
Product Code | PPN |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-06-27 |
Decision Date | 2022-08-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00195451000416 | K221852 | 000 |
00195451000409 | K221852 | 000 |
00195451000393 | K221852 | 000 |
00195451000386 | K221852 | 000 |