The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Enguard Phx Cardioplegia Heat Exchanger.
| Device ID | K991137 |
| 510k Number | K991137 |
| Device Name: | ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Contact | Lynn Lueders |
| Correspondent | Lynn Lueders MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-05 |
| Decision Date | 2000-06-08 |
| Summary: | summary |