LWE · Bone Marrow Collection/Transfusion Kit
· Class 2
Overview
| Product Code | LWE |
|---|---|
| Device Name | Bone Marrow Collection/Transfusion Kit |
| Device Class | Class 2 |
| Review Panel |
Identification
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952350 | JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) | Promedical , Ltd. | Jul 17, 1995 | SESE |
| K913306 | BONE-TEMNO/STERNUM-TEMNO | Proact, Ltd. | Nov 1, 1991 | SESE |
| K871198 | BONE MARROW COLLECTION KIT AND STAND | Baxter Healthcare Corp | Nov 6, 1987 | SESE |
Top Applicants
- Baxter Healthcare Corp — 1 clearance
- Proact, Ltd. — 1 clearance
- Promedical , Ltd. — 1 clearance
