The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Attain Select 6238tel Guide Catheter Set For Left-heart Delivery.
| Device ID | K042194 |
| 510k Number | K042194 |
| Device Name: | ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE Minneapolis, MN 55432 |
| Contact | Lynn Jensen |
| Correspondent | Lynn Jensen MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE Minneapolis, MN 55432 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-12 |
| Decision Date | 2004-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074058702 | K042194 | 000 |