ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
FDA 510(k) clearance K143164 · decided 2014-12-02
Clearance details
- K-number
- K143164
- Device name
- ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
- Applicant
- Kimberly-Clark Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-11-03
- Decision date
- 2014-12-02
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- BSO
- Device class
- 2
- Regulation number
- 868.5120
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.