Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
FDA 510(k) clearance K180958 · decided 2018-07-26
Clearance details
- K-number
- K180958
- Device name
- Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
- Applicant
- Shockwave Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-04-12
- Decision date
- 2018-07-26
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- PPN
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.