FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.
K Number: K052965
·
Decision Feb 13, 2006
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
27
Applicant Total
15
Review Days
115
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Basic Information
- Device Name
- EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.
- K Number
- K052965
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guidant Corporation
- Date Received
- October 21, 2005
- Decision Date
- February 13, 2006
- Product Code
- DRB
- 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 |
|---|---|---|---|
| DRB | Stylet, Catheter | FDA class 2 | Cardiovascular |
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| K041981 | GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 | Aug 20, 2004 | Substantially Equivalent |
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