The following data is part of a premarket notification filed by Carefusion with the FDA for Jamshidi Bone Marrow Biopsy/aspiration Needle, Jamshidi T-handle Bone Marrow Biopsy/aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/aspiration Needle.
| Device ID | K171531 |
| 510k Number | K171531 |
| Device Name: | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle |
| Classification | Instrument, Biopsy |
| Applicant | CareFusion 75 North Fairway Drive Vernon Hills, IL 60061 |
| Contact | Tamara Brey |
| Correspondent | Tamara Brey CareFusion 75 North Fairway Drive Vernon Hills, IL 60061 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-25 |
| Decision Date | 2017-09-11 |
| Summary: | summary |