The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Affinity Pediatric Arterial Filter, Model S4014 And With Carmeda Bioactive Surface, Model Cb4014.
| Device ID | K071253 |
| 510k Number | K071253 |
| Device Name: | AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Contact | Jessica Sixberry |
| Correspondent | Jessica Sixberry MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-04 |
| Decision Date | 2007-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994404897 | K071253 | 000 |
| 20613994309338 | K071253 | 000 |
| 20643169858910 | K071253 | 000 |
| 20643169767724 | K071253 | 000 |