TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)
FDA 510(k) clearance K090961 · decided 2009-06-12
Clearance details
- K-number
- K090961
- Device name
- TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)
- Applicant
- Twin Star Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-06
- Decision date
- 2009-06-12
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- LXC
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.