510(k) K211044
K211044 is an FDA 510(k) premarket notification submitted by Creagh Medical Ltd. (A Wholly Owned Subsidiary Of Surmodics, for the device "Sublime Radial Access 018 RX Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on Jun 16, 2021. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 16, 2021
- Date Received
- Apr 8, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)