The following data is part of a premarket notification filed by Shockwave Medical, Inc. with the FDA for Peripheral Intravascular Lithotripsy (ivl) Catheters, Ivl Generator And Connector Cable Kit, Ivl Connector Cable (replacement).
Device ID | K191840 |
510k Number | K191840 |
Device Name: | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator And Connector Cable Kit, IVL Connector Cable (Replacement) |
Classification | Percutaneous Catheter, Ultrasound |
Applicant | Shockwave Medical, Inc. 5403 Betsy Ross Drive Santa Clara, CA 95054 |
Contact | Cindy Morrow |
Correspondent | Cindy Morrow Shockwave Medical, Inc. 5403 Betsy Ross Drive Santa Clara, CA 95054 |
Product Code | PPN |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-07-09 |
Decision Date | 2019-08-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00195451000072 | K191840 | 000 |
00195451000065 | K191840 | 000 |
00195451000058 | K191840 | 000 |
00195451000041 | K191840 | 000 |
00195451000300 | K191840 | 000 |
00195451000294 | K191840 | 000 |
00195451000461 | K191840 | 000 |