FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K Number: K172687
·
Decision Nov 27, 2017
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
17
Review Days
82
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Basic Information
- Device Name
- Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- K Number
- K172687
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectranetics, Inc.
- Date Received
- September 6, 2017
- Decision Date
- November 27, 2017
- 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 |
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Other Clearances by Spectranetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) | Dec 15, 2022 | Substantially Equivalent |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Dec 8, 2022 | Substantially Equivalent |
| K212784 | TightRail Guardian Motorized Dilator Sheath | Aug 24, 2022 | Substantially Equivalent |
| DEN210024 | CavaClear Laser Sheath | Dec 21, 2021 | Unknown |
| K203540 | Bridge Occlusion Balloon | Dec 23, 2020 | Substantially Equivalent |
| K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Apr 5, 2018 | Substantially Equivalent |
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters | Apr 7, 2017 | Substantially Equivalent |
| K162561 | Turbo-Power (2.0mm) Laser Atherectomy Catheters | Jan 5, 2017 | Substantially Equivalent |
| K161333 | TightRail Sub-C Rotating Dilator Sheath | Jul 8, 2016 | Substantially Equivalent |
| K153530 | Bridge Occlusion Balloon | Feb 5, 2016 | Substantially Equivalent |