FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER CONNECTIONS DUALCAP SOLO
K Number: K123065
·
Decision Dec 14, 2012
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
21
Applicant Total
7
Review Days
74
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Basic Information
- Device Name
- CATHETER CONNECTIONS DUALCAP SOLO
- K Number
- K123065
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Catheter Connections, Inc.
- Date Received
- October 1, 2012
- Decision Date
- December 14, 2012
- Product Code
- QBP
- 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 |
|---|---|---|---|
| QBP | Cap, Device Disinfectant | FDA class 2 | General Hospital |
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Other Clearances by Catheter Connections, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142806 | DualCap | May 22, 2015 | Substantially Equivalent |
| K142399 | DualCap IV Pole Strips(Disinfectant Caps for Male Luers) | Nov 19, 2014 | Substantially Equivalent |
| K123967 | CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS | Jan 22, 2013 | Substantially Equivalent |
| K113842 | CATHETER CONNECTIONS' DUALCAP SOLO | Jan 27, 2012 | Substantially Equivalent |
| K112985 | CATHETER CONNECTIONS' DUALCAP DUO | Nov 9, 2011 | Substantially Equivalent |
| K093229 | CATHETER CONNECTIONS DUALCAP | Apr 8, 2010 | Substantially Equivalent |