The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Aspira Pleural Drainage System.
| Device ID | K071095 |
| 510k Number | K071095 |
| Device Name: | ASPIRA PLEURAL DRAINAGE SYSTEM |
| Classification | Apparatus, Suction, Patient Care |
| Applicant | BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City, UT 84116 |
| Contact | Jihyun Kim |
| Correspondent | Bradley Bonnette CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | DWM |
| CFR Regulation Number | 870.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-04-18 |
| Decision Date | 2007-05-18 |
| Summary: | summary |