FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable
K Number: K161384
·
Decision Sep 14, 2016
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
11
Applicant Total
12
Review Days
118
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Basic Information
- Device Name
- Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable
- K Number
- K161384
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shockwave Medical, Inc.
- Date Received
- May 19, 2016
- Decision Date
- September 14, 2016
- Product Code
- PPN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PPN | Percutaneous Catheter, Ultrasound | FDA class 2 | Cardiovascular |
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Other Clearances by Shockwave Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243757 | Shockwave CS Guide Catheter | May 2, 2025 | Substantially Equivalent |
| K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | Sep 27, 2024 | Substantially Equivalent |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | May 7, 2024 | Substantially Equivalent |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Mar 22, 2024 | Substantially Equivalent |
| K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Aug 16, 2022 | Substantially Equivalent |
| K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | Apr 25, 2022 | Substantially Equivalent |
| K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter | Apr 22, 2021 | Substantially Equivalent |
| K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | Aug 7, 2019 | Substantially Equivalent |
| K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable | Jul 26, 2018 | Substantially Equivalent |
| K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System | Jun 27, 2018 | Substantially Equivalent |