510(k) K212675 ยท PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Aspira Peritoneal Drainage System
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Unknown, Dec 14, 2021 |
| Received | Aug 24, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212675
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.