510(k) K022511 ยท MIB Elastomer, Silicone Block
AART CALF IMPLANT
| Applicant | Aesthetic and Reconstructive Technologies, Inc., Paso Robles CA, US |
| Decision | Substantially Equivalent, Aug 26, 2002 |
| Received | Jul 30, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022511
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | DSAART LLC Brand Name: AART Calf Implant
Product Name: Calf Implant
Model/Catalog Number:
502-103 - Calf Implant style 1 size 3
UDI-DI code: B490502103
502-104 - Calf Implant style 1 size 4
UDI-DI code: B490502 Open, Classified |
MIB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.