FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LV-1 HEMOSTASIS VALVE, MODEL #6789
K Number: K021282
·
Decision May 2, 2002
Classifications
1
FEI Numbers
143
Registration Numbers
144
Same Product Code
136
Applicant Total
71
Review Days
14
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Basic Information
- Device Name
- LV-1 HEMOSTASIS VALVE, MODEL #6789
- K Number
- K021282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guidant Corp.
- Date Received
- April 18, 2002
- Decision Date
- May 2, 2002
- Product Code
- DTL
- 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 |
|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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