FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITAL 5 RELEAF CATHETER
K Number: K122661
·
Decision Feb 27, 2013
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
74
Applicant Total
1
Review Days
180
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Basic Information
- Device Name
- VITAL 5 RELEAF CATHETER
- K Number
- K122661
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5120
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vital 5
- Date Received
- August 31, 2012
- Decision Date
- February 27, 2013
- Product Code
- BSO
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| BSO | Catheter, Conduction, Anesthetic | FDA class 2 | Anesthesiology |
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