Panels › Cardiovascular › Product code DWM · Class 2
Apparatus, Suction, Patient Care
Regulation 870.5050
0510(k)s in 12 months (19 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in DWM
| Company | 510(k)s | Recalls |
|---|---|---|
| Care Fusion | 4 | 0 |
| Pfm Medical, Inc. | 1 | 2 |
| Rocket Medical Plc | 3 | 0 |
| Bearpac Medical | 2 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Denver Biomedical, Inc. | 2 | 0 |
| Denver Biomedicals, Inc. | 2 | 0 |
| Bard Access Systems, Inc. | 1 | 0 |
| Denver Biomaterials, Inc. | 1 | 0 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Sterile Model Number: 4992301. Open, Classified |
DWM | K110409 |
| Dec 12, 2014 | Pfm Medical Inc ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052
Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from t Terminated |
DWM | K093307 |
| Dec 12, 2014 | Pfm Medical Inc ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001
Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain acc Terminated |
DWM | K093307 |
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