Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)— 510(k) K191840
Substantially EquivalentShockwave Medical, Inc.
FDA 510(k) clearance K191840 for Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement), Substantially Equivalent on 2019-08-07. Applicant: Shockwave Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Shockwave Medical, Inc.
- Product code
- Code PPN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Santa Clara, CA, US
Recent devices under product code PPN
view all- K260246 — SEISMIQ Intravascular Lithotripsy System
- K262201 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
- K250225 — Bolt Intravascular Lithotripsy (IVL) System
- K242213 — Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter
- K240954 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
More clearances from Shockwave Medical, Inc.
view all- K243757 — Shockwave CS Guide Catheter
- K240225 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
- K221852 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
- K221041 — Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
- K203365 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter
Adverse events under product code PPN
product code PPN- Death
- 16
- Total
- 16
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.