The following data is part of a premarket notification filed by Medtronic Ave, Inc. with the FDA for Wire, Guide, Catheter, Model Qsw1000.
| Device ID | K002346 |
| 510k Number | K002346 |
| Device Name: | WIRE, GUIDE, CATHETER, MODEL QSW1000 |
| Classification | Wire, Guide, Catheter |
| Applicant | MEDTRONIC AVE, INC. 1660 WAYZATA BLVD. Minnetonka, MN 55305 |
| Contact | Linda (linn) Laak |
| Correspondent | Linda (linn) Laak MEDTRONIC AVE, INC. 1660 WAYZATA BLVD. Minnetonka, MN 55305 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-02 |
| Decision Date | 2000-09-27 |