FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pantera Pro; Pantera LEO
K Number: K242969
·
Decision Oct 25, 2024
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
85
Applicant Total
85
Review Days
29
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Basic Information
- Device Name
- Pantera Pro; Pantera LEO
- K Number
- K242969
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biotronik, Inc.
- Date Received
- September 26, 2024
- Decision Date
- October 25, 2024
- Product Code
- LOX
- 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 |
|---|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Biotronik, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261074 | BIOMONITOR IV (471155) | May 1, 2026 | Substantially Equivalent |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | Apr 4, 2025 | Substantially Equivalent |
| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) | Sep 12, 2024 | Substantially Equivalent |
| K241711 | Oscar Peripheral Multifunctional Catheter system | Jul 11, 2024 | Substantially Equivalent |
| K230375 | BIOMONITOR IV | May 19, 2023 | Substantially Equivalent |
| K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | Feb 16, 2023 | Substantially Equivalent |
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | Jul 27, 2022 | Substantially Equivalent |
| K222037 | Selectra Lead Implantation System | Jul 19, 2022 | Substantially Equivalent |
| K214038 | Oscar Peripheral Multifunctional Catheter system | Jul 6, 2022 | Substantially Equivalent |
| K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter | Sep 2, 2021 | Substantially Equivalent |