510(k) K021337 ยท MIC Implant, Muscle, Pectoralis
AART PECTORALIS IMPLANT
| Applicant | Aesthetic and Reconstructive Technologies, Inc., Paso Robles CA, US |
| Decision | Substantially Equivalent, Jul 3, 2002 |
| Received | Apr 26, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021337
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | DSAART LLC Brand Name: AART Pectoral Implant
Product Name: Pectoral Implant
Model/Catalog Number:
500-106-5 Pectoral Implant style 1 size 6 left
UDI-DI code: B4905001065
500-106-6 Pectoral Implant style 1 size Open, Classified |
MIC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.