Hemafuse System
FDA 510(k) clearance K210862 · decided 2021-07-29
Clearance details
- K-number
- K210862
- Device name
- Hemafuse System
- Applicant
- Sisu Global Health
- Decision
- Substantially Equivalent
- Date received
- 2021-03-23
- Decision date
- 2021-07-29
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Baltimore, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sisu Global Health
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.