510(k) K053431
K053431 is an FDA 510(k) premarket notification submitted by Medtronic, Ireland for the device "ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on March 16, 2006. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Medtronic, Ireland has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2006
- Date Received
- December 9, 2005
- Clearance Type
- Traditional
- 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