510(k) clearance
OAB Delivery Catheter
- 510(k) number
- K253422
- Applicant
- Cognition Medical Corp.
- Decision date
- Oct 2, 2026
- Date received
- Oct 1, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QJP
- Device type
- Catheter, Percutaneous, Neurovasculature
- Device class
- Class II
- Regulation
- 21 CFR 870.1250
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Atlanta, GA, US