FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H
K Number: K060655
·
Decision Apr 4, 2006
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
85
Review Days
22
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Basic Information
- Device Name
- SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H
- K Number
- K060655
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biotronik, Inc.
- Date Received
- March 13, 2006
- Decision Date
- April 4, 2006
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Biotronik, Inc.
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|---|---|---|---|
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| 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 |