510(k) K182399
K182399 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Park Blade Septostomy Catheter". The FDA issued a decision of Substantially Equivalent on April 4, 2019. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Cook Incorporated has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2019
- Date Received
- September 4, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Septostomy
- Device Class
- Class II
- Regulation Number
- 870.5175
- Review Panel
- CV
- Submission Type