AART PECTORALIS IMPLANT
FDA 510(k) clearance K021337 · decided 2002-07-03
Clearance details
- K-number
- K021337
- Device name
- AART PECTORALIS IMPLANT
- Applicant
- Aesthetic and Reconstructive Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-26
- Decision date
- 2002-07-03
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- MIC
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Paso Robles, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SILMAX PECTORAL IMPLANT (K002633) | Pillar Surgical, Inc. | 2000-11-21 |
| SEARE BIOMEDICAL PECTORALIS IMPLANT (K982762) | Seare Biomedical Corp. | 1998-09-30 |
| SEARE BIOMEDICAL SILICONE BLOCK (K983043) | Seare Biomedical Corp. | 1998-09-30 |
| POWERFLEX PEC IMPLANT (K973729) | Hanson Medical, Inc. | 1997-12-24 |
| PEC IMPLANT (K961072) | Rand Scientific Corp. | 1996-04-19 |
| SPECTRUM DISIGNS PECTORAL IMPLANT (K944163) | Spectrum Designs, Inc. | 1994-11-07 |
| PEC IMPLANT (K913768) | Applied Biomaterial Technologies | 1992-02-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500 recall (Z-0948-2026) | DSAART LLC | 2025-12-18 |