The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Vision Cardioplegia Delivery System.
| Device ID | K964571 |
| 510k Number | K964571 |
| Device Name: | VISION CARDIOPLEGIA DELIVERY SYSTEM |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | LIFESTREAM INT'L, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson, R.n., Rac |
| Correspondent | Rosina Robinson, R.n., Rac LIFESTREAM INT'L, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-14 |
| Decision Date | 1997-08-08 |
| Summary: | summary |