FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
K Number: K022718
·
Decision Aug 28, 2002
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
8
Review Days
13
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Basic Information
- Device Name
- VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
- K Number
- K022718
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guidant Corporation, Cardiac Surgery
- Date Received
- August 15, 2002
- Decision Date
- August 28, 2002
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
| K080169 | HEARTSTRING III PROXIMAL SEAL SYSTEM | Feb 8, 2008 | Substantially Equivalent |
| K041340 | GUIDANT MICROWAVE ABLATION SYSTEM | Jul 28, 2004 | Substantially Equivalent |
| K023630 | ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 | Feb 20, 2003 | Substantially Equivalent |
| K024071 | GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM | Feb 14, 2003 | Substantially Equivalent |
| K023629 | ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 | Nov 12, 2002 | Substantially Equivalent |
| K020701 | SYNCRUS INTERNAL CARDIOVERSION SYSTEM | May 24, 2002 | Substantially Equivalent |
| K020143 | VASOVIEW 5 HARVESTING CANNULA | Feb 20, 2002 | Substantially Equivalent |