FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
K Number: K190634
·
Decision Jul 2, 2019
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
26
Review Days
112
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Basic Information
- Device Name
- Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
- K Number
- K190634
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiovascular Systems, Inc.
- Date Received
- March 12, 2019
- Decision Date
- July 2, 2019
- Product Code
- MCW
- 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 |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
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Other Clearances by Cardiovascular Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K220109 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | Mar 1, 2022 | Substantially Equivalent |
| K212725 | ViperCross Support Catheters | Sep 24, 2021 | Substantially Equivalent |
| K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system | Sep 14, 2021 | Substantially Equivalent |
| K211240 | ViperCross Support Catheters | Aug 26, 2021 | Substantially Equivalent |
| K211251 | ViperCath XC Peripheral Exchange Catheter | May 26, 2021 | Substantially Equivalent |
| K210282 | WIRION Embolic Protection System | Mar 3, 2021 | Substantially Equivalent |
| K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | Nov 19, 2020 | Substantially Equivalent |
| K200198 | WIRION | Mar 18, 2020 | Substantially Equivalent |
| K183000 | ViperCath XC Peripheral Exchange Catheter | Dec 29, 2018 | Substantially Equivalent |
| K182397 | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | Dec 13, 2018 | Substantially Equivalent |