The following data is part of a premarket notification filed by Medtronic Inc., Cardiac Rhythm Management with the FDA for Attain Hybrid Guide Wires, Model Gwr419378, Gwr419388, Gwr419478, Gwr419488.
| Device ID | K063210 |
| 510k Number | K063210 |
| Device Name: | ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 |
| Classification | Wire, Guide, Catheter |
| Applicant | MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT 1015 GRAMSIE RD Shoreview, MN 55126 -3082 |
| Contact | Michelle Nivala |
| Correspondent | Michelle Nivala MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT 1015 GRAMSIE RD Shoreview, MN 55126 -3082 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-23 |
| Decision Date | 2007-03-15 |
| Summary: | summary |