The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Attain 6215 Venogram Balloon Catheter.
| Device ID | K012225 |
| 510k Number | K012225 |
| Device Name: | ATTAIN 6215 VENOGRAM BALLOON CATHETER |
| Classification | Catheter, Flow Directed |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
| Contact | Karen Reidt |
| Correspondent | Karen Reidt MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994842114 | K012225 | 000 |
| 00763000227982 | K012225 | 000 |