The following data is part of a premarket notification filed by Medtronic Ireland with the FDA for Sprinter Legend 1.25mm Rx And Sprinter Legend 1.25mm Otw Balloon.
| Device ID | K103095 |
| 510k Number | K103095 |
| Device Name: | SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | MEDTRONIC IRELAND 3576 Unocal Place Santa Rosa, CA 95403 |
| Contact | Gerardine Finn |
| Correspondent | Gerardine Finn MEDTRONIC IRELAND 3576 Unocal Place Santa Rosa, CA 95403 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-08 |
| Decision Date | 2010-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169019010 | K103095 | 000 |
| 00643169271753 | K103095 | 000 |
| 00643169271760 | K103095 | 000 |
| 00643169271777 | K103095 | 000 |
| 00643169271784 | K103095 | 000 |
| 00643169854932 | K103095 | 000 |
| 00643169854949 | K103095 | 000 |
| 00643169854956 | K103095 | 000 |
| 00643169854963 | K103095 | 000 |
| 00643169854970 | K103095 | 000 |
| 00643169018983 | K103095 | 000 |
| 00643169018990 | K103095 | 000 |
| 00643169019003 | K103095 | 000 |
| 00643169271746 | K103095 | 000 |