The following data is part of a premarket notification filed by Carefusion with the FDA for Bd Curve Ascites Shunt.
| Device ID | K170405 |
| 510k Number | K170405 |
| Device Name: | BD Curve Ascites Shunt |
| Classification | Shunt, Peritoneal |
| 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 | KPM |
| CFR Regulation Number | 876.5955 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-10 |
| Decision Date | 2017-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885403460393 | K170405 | 000 |