FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
K Number: K221986
·
Decision Oct 18, 2022
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
44
Applicant Total
5
Review Days
104
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Basic Information
- Device Name
- XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
- K Number
- K221986
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Transit Scientific, LLC
- Date Received
- July 6, 2022
- Decision Date
- October 18, 2022
- Product Code
- PNO
- 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 |
|---|---|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring | FDA class 2 | Cardiovascular |
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Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Transit Scientific, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K232258 | XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter | Jun 17, 2024 | Substantially Equivalent |
| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) | Nov 29, 2023 | Substantially Equivalent |
| K214107 | XO CROSS CORONARY Support Catheter | Apr 11, 2022 | Substantially Equivalent |
| K210322 | XO Cross Support Catheter | Oct 21, 2021 | Substantially Equivalent |