Terumo Circuit Tubing
FDA 510(k) clearance K150536 · decided 2015-05-05
Clearance details
- K-number
- K150536
- Device name
- Terumo Circuit Tubing
- Applicant
- Terumo Cardiovascular Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-03-03
- Decision date
- 2015-05-05
- Days to decision
- 63 days
- Clearance type
- Special
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ashland, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Terumo Cardiovascular Systems Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.