The following data is part of a premarket notification filed by Jostra Medizintechnik Ag with the FDA for Quart Arterial Filter, Model Hbf 140.
| Device ID | K001787 |
| 510k Number | K001787 |
| Device Name: | QUART ARTERIAL FILTER, MODEL HBF 140 |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | JOSTRA MEDIZINTECHNIK AG 2035 SUNSET LAKE RD. Newark, DE 19702 |
| Contact | Kathy Johnson |
| Correspondent | Kathy Johnson JOSTRA MEDIZINTECHNIK AG 2035 SUNSET LAKE RD. Newark, DE 19702 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-13 |
| Decision Date | 2000-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691190402 | K001787 | 000 |