FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pro-Lock CT Safety Infusion Set
K Number: K162271
·
Decision Apr 26, 2017
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
12
Applicant Total
6
Review Days
257
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Basic Information
- Device Name
- Pro-Lock CT Safety Infusion Set
- K Number
- K162271
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medcomp (Medical Components, Inc.)
- Date Received
- August 12, 2016
- Decision Date
- April 26, 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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Other Clearances by Medcomp (Medical Components, Inc.)
| K Number | Device Name | ||
|---|---|---|---|
| K171931 | Celerity ECG Cable Accessory Pack | Oct 26, 2017 | Substantially Equivalent |
| K153246 | PTFE Super Sheath Introducer 2.1 | Feb 12, 2016 | Substantially Equivalent |
| K141151 | CT MIDLINE | Jul 8, 2014 | Substantially Equivalent |
| K140799 | CELERITY SYSYEM | Jun 13, 2014 | Substantially Equivalent |
| K132498 | VALVED TEARAWAY INTRODUCER GENERATION II | Nov 25, 2013 | Substantially Equivalent |