SelectFlex 072 Neurovascular Access System
FDA 510(k) clearance K181000 · decided 2018-09-13
Clearance details
- K-number
- K181000
- Device name
- SelectFlex 072 Neurovascular Access System
- Applicant
- Q'Apel
- Decision
- Substantially Equivalent
- Date received
- 2018-04-16
- Decision date
- 2018-09-13
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Monica, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Q'Apel
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.