The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Aspira Peritoneal Drainage System.
| Device ID | K110396 |
| 510k Number | K110396 |
| Device Name: | ASPIRA PERITONEAL DRAINAGE SYSTEM |
| Classification | Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling |
| Applicant | C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Henry Boland |
| Correspondent | Henry Boland C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Product Code | PNG |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-11 |
| Decision Date | 2011-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450394899 | K110396 | 000 |
| 10884450398163 | K110396 | 000 |
| 10884450394905 | K110396 | 000 |
| 10884450394875 | K110396 | 000 |