Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
FDA 510(k) clearance K232852 · decided 2023-10-12
Clearance details
- K-number
- K232852
- Device name
- Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
- Applicant
- Cross Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-14
- Decision date
- 2023-10-12
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DXF
- Device class
- 2
- Regulation number
- 870.5175
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Solana Beach, CA, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cross Vascular
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.