FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONVOY ADVANCED DELIVERY SHEATH KIT
K Number: K013866
·
Decision Dec 14, 2001
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
58
Review Days
23
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Basic Information
- Device Name
- CONVOY ADVANCED DELIVERY SHEATH KIT
- K Number
- K013866
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 866.5520
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific
- Date Received
- November 21, 2001
- Decision Date
- December 14, 2001
- Product Code
- DBY
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DBY | Fab, Rhodamine, Antigen, Antiserum, Control | FDA class 1 | Immunology |
Similar 510(k) Clearances
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