Flexitouch System
FDA 510(k) clearance K153311 · decided 2016-09-14
Clearance details
- K-number
- K153311
- Device name
- Flexitouch System
- Applicant
- Tactile Systems Technology, Inc. (Dba Tactile Medical)
- Decision
- Substantially Equivalent
- Date received
- 2015-11-17
- Decision date
- 2016-09-14
- Days to decision
- 302 days
- Clearance type
- Traditional
- Product code
- PPS
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.