The following data is part of a premarket notification filed by Cardio Metrics, Inc. with the FDA for Drainovac Complete Closed Wound Drainage Device.
| Device ID | K863482 |
| 510k Number | K863482 |
| Device Name: | DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | CARDIO METRICS, INC. 10415 LANDSBURY DR. Houston, TX 77099 |
| Contact | Cathy Spiller |
| Correspondent | Cathy Spiller CARDIO METRICS, INC. 10415 LANDSBURY DR. Houston, TX 77099 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-10-14 |