510(k) K231311
K231311 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "CPS Direct Universal slittable outer guide catheter (DS2C029)". The FDA issued a decision of Substantially Equivalent on Jun 2, 2023. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. ABBOTT MEDICAL has 59 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 2, 2023
- Date Received
- May 5, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)