Panels › Gastroenterology, Urology › Product code PNG · Class 2
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Regulation 876.5630
0510(k)s in 12 months (15 all time)
0recalls in 12 months (13 all time)
13recalls that name a 510(k)
Top companies in PNG
| Company | 510(k)s | Recalls |
|---|---|---|
| Merit Medical Systems, Inc. | 1 | 13 |
| Care Fusion | 4 | 0 |
| Pfm Medical, Inc. | 3 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Rocket Medical Plc | 2 | 0 |
| Bard Peripheral Vascular, Inc. | 1 | 0 |
| Bearpac Medical | 1 | 0 |
| Denver Biomedical, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K110396 K212675 |
| 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 | K110396 K212675 |
| 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 | K110396 K212675 |
| 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 | K110396 K212675 |
| Jun 14, 2023 | Merit Medical Systems, Inc. Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only Open, Classified |
PNG | K110396 K212675 |
| 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 | K110396 K212675 |
| 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 | K110396 K212675 |
| 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 | K110396 K212675 |
| 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 | K110396 K212675 |
| 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 | K110396 K212675 |
| 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 | K110396 K212675 |
| 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 | K110396 K212675 |
| 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 | K110396 K212675 |
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