FDA 510(k)
FDA class 3
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
K Number: K952328
·
Decision Sep 29, 1995
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
85
Review Days
134
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Basic Information
- Device Name
- NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
- K Number
- K952328
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Biotronik, Inc.
- Date Received
- May 18, 1995
- Decision Date
- September 29, 1995
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXY), ordered by most recent decision date.
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
FDA 510(k)
FDA Class 3
·Cardiovascular
OPUS S MODEL 4121 AND 4124 PACEMAKERS
FDA 510(k)
FDA Class 3
·Cardiovascular
PIKOS LP 01, PIKOS LP E01
FDA 510(k)
FDA Class 3
·Cardiovascular
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
FDA 510(k)
FDA Class 3
·Cardiovascular
Other Clearances by Biotronik, Inc.
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|---|---|---|---|
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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 |