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
28
Registration Numbers
28
Same Product Code
460
Applicant Total
64
Review Days
29
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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Other Clearances by BIOTRONIK, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| K152240 | Passeo-14 Peripheral Dilatation Catheter | Oct 8, 2015 | Substantially Equivalent |
| K151744 | Passeo-18 Peripheral Dilation Catheter | Oct 8, 2015 | Substantially Equivalent |
| K151409 | Selectra Catheters and Selectra Accessory Kit | Aug 7, 2015 | Unknown |
| K143503 | BioMonitor | Mar 19, 2015 | Substantially Equivalent |
| K142379 | Passeo-35 PTA Catheter | Dec 5, 2014 | Substantially Equivalent |
| K132960 | BIOMONITOR | Jun 6, 2014 | Substantially Equivalent |
| K131978 | SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL | Aug 23, 2013 | Substantially Equivalent |
| K130161 | PASSEO-35 | Apr 23, 2013 | Substantially Equivalent |