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 | K081288 |
510k Number | K081288 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-05-07 |
Decision Date | 2008-07-18 |
Summary: | summary |