The following data is part of a premarket notification filed by Janus Biomedical, Inc. with the FDA for Jostra Hl-20 Integrated Perfusion System.
| Device ID | K943803 |
| 510k Number | K943803 |
| Device Name: | JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | JANUS BIOMEDICAL, INC. 2525 HARTFORD RD. Austin, TX 78703 |
| Contact | Richard Martin |
| Correspondent | Richard Martin JANUS BIOMEDICAL, INC. 2525 HARTFORD RD. Austin, TX 78703 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-04 |
| Decision Date | 1996-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691253114 | K943803 | 000 |
| 04037691261386 | K943803 | 000 |
| 04037691276717 | K943803 | 000 |
| 04037691289939 | K943803 | 000 |
| 04037691457659 | K943803 | 000 |
| 04037691585598 | K943803 | 000 |
| 04037691762326 | K943803 | 000 |
| 04037691477206 | K943803 | 000 |
| 04037691477251 | K943803 | 000 |
| 04037691786544 | K943803 | 000 |
| 04037691260129 | K943803 | 000 |