510(k) K113468
K113468 is an FDA 510(k) premarket notification submitted by Creagh Medical, Ltd. for the device "ELM PTA BALLON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on December 20, 2011. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Creagh Medical, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2011
- Date Received
- November 22, 2011
- 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