The following data is part of a premarket notification filed by Medtronic Ave, Inc. with the FDA for Catheter, Intravascular Occluding, Temporary, Model Sol 3510; Wire, Guide, Catheter, Model Qsw1000.
| Device ID | K994141 |
| 510k Number | K994141 |
| Device Name: | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | MEDTRONIC AVE, INC. 3576 UNOCAL PL. Santa Rosa, CA 95403 |
| Contact | Shelly Trimm |
| Correspondent | Shelly Trimm MEDTRONIC AVE, INC. 3576 UNOCAL PL. Santa Rosa, CA 95403 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-08 |
| Decision Date | 2000-07-21 |
| Summary: | summary |