The following data is part of a premarket notification filed by Carefusion with the FDA for Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion Stylet, Pleurx Integral Valved Pee.
| Device ID | K121849 |
| 510k Number | K121849 |
| Device Name: | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE |
| Classification | Apparatus, Suction, Patient Care |
| Applicant | CAREFUSION 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Joy Greidanus |
| Correspondent | Joy Greidanus CAREFUSION 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | DWM |
| CFR Regulation Number | 870.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-25 |
| Decision Date | 2012-10-18 |
| Summary: | summary |