CATHETER CONNECTIONS' DUALCAP DUO
FDA 510(k) clearance K112985 · decided 2011-11-09
Clearance details
- K-number
- K112985
- Device name
- CATHETER CONNECTIONS' DUALCAP DUO
- Applicant
- Catheter Connections, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-06
- Decision date
- 2011-11-09
- Days to decision
- 34 days
- Clearance type
- Special
- Product code
- QBP
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.