K191840 is an FDA 510(k) clearance for the Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement). This device is classified as a Percutaneous Catheter, Ultrasound (Class II - Special Controls, product code PPN).
Submitted by Shockwave Medical, Inc. (Santa Clara, US). The FDA issued a Cleared decision on August 7, 2019, 29 days after receiving the submission on July 9, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250. Intended For Ultrasound Wave Enhanced Balloon Dilatation Of Lesions, Including Calcified Lesions, In The Peripheral Vasculature..
| 510(k) Number | K191840 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2019 |
| Decision Date | August 07, 2019 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PPN - Percutaneous Catheter, Ultrasound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | Intended For Ultrasound Wave Enhanced Balloon Dilatation Of Lesions, Including Calcified Lesions, In The Peripheral Vasculature. |