SAM JUNCTIONAL TOURNIQUET
FDA 510(k) clearance K123694 · decided 2013-03-07
Clearance details
- K-number
- K123694
- Device name
- SAM JUNCTIONAL TOURNIQUET
- Applicant
- Sam Medical Products
- Decision
- Substantially Equivalent
- Date received
- 2012-12-03
- Decision date
- 2013-03-07
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wilsonville, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models speci recall (Z-0133-2015) | Sam Medical Products | 2014-12-16 |