The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Arterial 20/40 Micron Filters W/wo Heparin Coating.
| Device ID | K864262 |
| 510k Number | K864262 |
| Device Name: | ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
| Contact | Denise Carpenter |
| Correspondent | Denise Carpenter JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-29 |
| Decision Date | 1987-01-02 |