The following data is part of a premarket notification filed by Jostra Bentley with the FDA for Jostra Hl-15 Modular Heart-lung Machine (hereinafter Called The Hl-15 Or The Device.
| Device ID | K945720 |
| 510k Number | K945720 |
| Device Name: | JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | JOSTRA BENTLEY 2525 HARTFORD RD. Austin, TX 78703 |
| Contact | Richard Martin |
| Correspondent | Richard Martin JOSTRA BENTLEY 2525 HARTFORD RD. Austin, TX 78703 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-21 |
| Decision Date | 1995-03-29 |