The following data is part of a premarket notification filed by Cardioquip Llp with the FDA for Cardioquip Modular Cooler-heater Model Mch-1000.
| Device ID | K102147 |
| 510k Number | K102147 |
| Device Name: | CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | CARDIOQUIP LLP 3827 OLD COLLEGE RD Bryan, TX 77801 |
| Contact | Douglas Platt |
| Correspondent | Douglas Platt CARDIOQUIP LLP 3827 OLD COLLEGE RD Bryan, TX 77801 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-30 |
| Decision Date | 2010-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000846134 | K102147 | 000 |
| 00860000846127 | K102147 | 000 |
| 00860000846110 | K102147 | 000 |
| 00860000846103 | K102147 | 000 |