510(k) K110396 ยท PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
ASPIRA PERITONEAL DRAINAGE SYSTEM
| Applicant | C.R. Bard, Inc., Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, May 6, 2011 |
| Received | Feb 11, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110396
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only Open, Classified |
PNG | None listed |
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only Open, Classified |
PNG | None listed |
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only Open, Classified |
PNG | None listed |
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only Open, Classified |
PNG | None listed |
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only Open, Classified |
PNG | None listed |
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only Open, Classified |
PNG | None listed |
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only Open, Classified |
PNG | None listed |
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only Open, Classified |
PNG | None listed |
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only Open, Classified |
PNG | None listed |
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only Open, Classified |
PNG | None listed |
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only Open, Classified |
PNG | None listed |
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only Open, Classified |
PNG | None listed |
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only Open, Classified |
PNG | None listed |
| Aug 8, 2011 | Bard Access Systems Bard Aspira Drainage Kit, Product Code 4991502.
The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended Terminated |
FJS | None listed |
| Aug 8, 2011 | Bard Access Systems Bard Aspira Dressing Kit, Product Code 4991503.
The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended f Terminated |
FJS | None listed |
| Aug 8, 2011 | Bard Access Systems Bard Aspira Luer Adapter, Product Code 4991505.
The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended f Terminated |
FJS | None listed |
| Aug 8, 2011 | Bard Access Systems Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506.
The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter Terminated |
FJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.