The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for 6248val Adjustable Valve.
| Device ID | K052459 |
| 510k Number | K052459 |
| Device Name: | 6248VAL ADJUSTABLE VALVE |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis, MN 55432 -3576 |
| Contact | Michelle Nivala |
| Correspondent | Michelle Nivala MEDTRONIC VASCULAR 7000 CENTRAL AVENUE NE MS CW304 Minneapolis, MN 55432 -3576 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-07 |
| Decision Date | 2006-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074439860 | K052459 | 000 |
| 00763000713041 | K052459 | 000 |