The following data is part of a premarket notification filed by Medtronic Ireland with the FDA for Attain Select Ii 6248del Delivery Catheter System.
| Device ID | K053431 |
| 510k Number | K053431 |
| Device Name: | ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC IRELAND 1015 GRAMSIE ROAD Shoreview, MN 55126 |
| Contact | Michelle Nivala |
| Correspondent | Michelle Nivala MEDTRONIC IRELAND 1015 GRAMSIE ROAD Shoreview, MN 55126 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-09 |
| Decision Date | 2006-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994746887 | K053431 | 000 |
| 00613994746832 | K053431 | 000 |
| 00613994746801 | K053431 | 000 |
| 00613994746627 | K053431 | 000 |
| 00613994746610 | K053431 | 000 |