LWEClass II
Bone Marrow Collection/Transfusion Kit
Unknown
LWE is the FDA product code for Bone Marrow Collection/Transfusion Kit, a class II device type. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- LWE
- Device name
- Bone Marrow Collection/Transfusion Kit
- FDA definition
- 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.
- Device class
- Class II
- Review panel
- Unknown
- Submission type
- FDA code 7
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 1
Clearances, product code LWE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1991 | 1 |
| 1995 | 1 |
Applicants with the most clearances
Product code LWE| Applicant | Clearances |
|---|---|
| Baxter Healthcare Corporation | 1 |
| Proact, Ltd. | 1 |
| Promedical, Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.