CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS
Device Facts
| Record ID | K011487 |
|---|---|
| Device Name | CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS |
| Applicant | Somanetics Corp. |
| Product Code | DXZ · Cardiovascular |
| Decision Date | Nov 21, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3470 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
