FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ArchFlo CT Midline
K Number: K171483
·
Decision Dec 15, 2017
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
12
Applicant Total
3
Review Days
207
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Basic Information
- Device Name
- ArchFlo CT Midline
- K Number
- K171483
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medcomp (Dba Medical Components, Inc.)
- Date Received
- May 22, 2017
- Decision Date
- December 15, 2017
- Product Code
- PND
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| PND | Midline Catheter | FDA class 2 | General Hospital |
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