FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
K Number: K993434
·
Decision Nov 10, 1999
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
85
Review Days
29
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Basic Information
- Device Name
- PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
- K Number
- K993434
- Device Class
- FDA class 3
- Clearance Type
- Special
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biotronik, Inc.
- Date Received
- October 12, 1999
- Decision Date
- November 10, 1999
- Product Code
- DXY
- 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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | FDA class 3 | Cardiovascular |
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NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
FDA 510(k)
FDA Class 3
·Cardiovascular
Other Clearances by Biotronik, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261074 | BIOMONITOR IV (471155) | May 1, 2026 | Substantially Equivalent |
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| K242969 | Pantera Pro; Pantera LEO | Oct 25, 2024 | 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 |