FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
20G x 5/8 Pro-Lock CT Safety Infusion Set
K Number: K171333
·
Decision Jul 18, 2017
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
12
Applicant Total
3
Review Days
71
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Basic Information
- Device Name
- 20G x 5/8 Pro-Lock CT Safety Infusion Set
- K Number
- K171333
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medcomp (Dba Medical Components, Inc.)
- Date Received
- May 8, 2017
- Decision Date
- July 18, 2017
- Product Code
- PTI
- 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 |
|---|---|---|---|
| PTI | Non-Coring (Huber) Needle | FDA class 2 | General Hospital |
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