The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Attain Clarity 6225 Venogram Balloon Catheter.
| Device ID | K121219 |
| 510k Number | K121219 |
| Device Name: | ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA STREET MS MVSII Mounds View, MN 55112 |
| Contact | Wendy Saunders |
| Correspondent | Wendy Saunders MEDTRONIC INC. 8200 CORAL SEA STREET MS MVSII Mounds View, MN 55112 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-23 |
| Decision Date | 2012-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169530102 | K121219 | 000 |
| 00643169181717 | K121219 | 000 |