The following data is part of a premarket notification filed by Medtronic Endovascular Innovations with the FDA for Reliant Stent Graft Balloon Catheter.
| Device ID | K050038 |
| 510k Number | K050038 |
| Device Name: | RELIANT STENT GRAFT BALLOON CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC ENDOVASCULAR INNOVATIONS 3576 Unocal Place Santa Rosa, CA 95403 |
| Contact | Willie Mitchell |
| Correspondent | Willie Mitchell MEDTRONIC ENDOVASCULAR INNOVATIONS 3576 Unocal Place Santa Rosa, CA 95403 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-07 |
| Decision Date | 2005-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169707641 | K050038 | 000 |
| 00643169164192 | K050038 | 000 |
| 00763000154134 | K050038 | 000 |
| 00763000200947 | K050038 | 000 |