The following data is part of a premarket notification filed by Carefusion with the FDA for Achieve Programmable Auomated Biopsy Systems.
| Device ID | K141552 |
| 510k Number | K141552 |
| Device Name: | ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS |
| Classification | Instrument, Biopsy |
| Applicant | CAREFUSION 75 NORTH FAIRWAY DRIVE Vernon Hills, IL 60061 |
| Contact | Joy Greidanus |
| Correspondent | Joy Greidanus 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 | 2014-06-11 |
| Decision Date | 2014-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450443730 | K141552 | 000 |
| 20884450444287 | K141552 | 000 |
| 20884450444256 | K141552 | 000 |
| 20884450444409 | K141552 | 000 |
| 20884450444263 | K141552 | 000 |
| 20884450444393 | K141552 | 000 |
| 20884450444348 | K141552 | 000 |
| 20884450443952 | K141552 | 000 |
| 20884450443907 | K141552 | 000 |
| 20884450443914 | K141552 | 000 |
| 20884450444362 | K141552 | 000 |
| 20884450443716 | K141552 | 000 |
| 20884450443723 | K141552 | 000 |
| 20884450444478 | K141552 | 000 |
| 20884450443945 | K141552 | 000 |
| 20884450443693 | K141552 | 000 |
| 20884450443785 | K141552 | 000 |
| 20884450444423 | K141552 | 000 |
| 20884450444430 | K141552 | 000 |
| 20884450444324 | K141552 | 000 |
| 20884450444317 | K141552 | 000 |
| 20884450443969 | K141552 | 000 |
| 20884450444485 | K141552 | 000 |
| 20884450443709 | K141552 | 000 |
| 20884450444454 | K141552 | 000 |
| 20884450444508 | K141552 | 000 |
| 20884450443938 | K141552 | 000 |
| 20884450444379 | K141552 | 000 |
| 20884450444201 | K141552 | 000 |