NEWCHILL(TM) CARDIAC INSULATOR
Device Facts
| Record ID | K892804 |
|---|---|
| Device Name | NEWCHILL(TM) CARDIAC INSULATOR |
| Applicant | Acacia Laboratories, Inc. |
| Product Code | DWS · Cardiovascular |
| Decision Date | Jul 14, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4500 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.
