FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONVOY ADVANCED DELIVERY SHEATH
K Number: K022067
·
Decision Sep 11, 2002
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
58
Review Days
78
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Basic Information
- Device Name
- CONVOY ADVANCED DELIVERY SHEATH
- K Number
- K022067
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5520
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific
- Date Received
- June 25, 2002
- Decision Date
- September 11, 2002
- 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 |
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