The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Aspira Pleural Drainage System.
| Device ID | K110409 |
| 510k Number | K110409 |
| Device Name: | ASPIRA PLEURAL DRAINAGE SYSTEM |
| Classification | Apparatus, Suction, Patient Care |
| 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 | DWM |
| CFR Regulation Number | 870.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2011-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450394865 | K110409 | 000 |
| 10884450394981 | K110409 | 000 |
| 10884450394950 | K110409 | 000 |
| 20884450394971 | K110409 | 000 |
| 10884450394967 | K110409 | 000 |
| 10884450394929 | K110409 | 000 |