Panels › General Hospital › Product code KMK · Class 1
Device, Intravascular Catheter Securement
Regulation 880.5210
0510(k)s in 12 months (64 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in KMK
| Company | 510(k)s | Recalls |
|---|---|---|
| Bard Access Systems | 0 | 4 |
| Ansley Medical Products, Inc. | 3 | 0 |
| Merit Medical Systems, Inc | 0 | 3 |
| Op-Co Medical Products , Ltd. | 3 | 0 |
| Consolidated Medical Equipment, Inc. | 2 | 0 |
| Dale Medical Products, Inc. | 2 | 0 |
| K-Lok, Inc. | 2 | 0 |
| Saxnor Corp. | 2 | 0 |
| Tnt Moborg Intl. , Ltd. | 2 | 0 |
| Vitaphore Corp. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2017 | Bard Access Systems Inc. StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 dev Terminated |
KMK | None listed |
| Jan 10, 2017 | Bard Access Systems StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 5 Terminated |
KMK | None listed |
| Jan 10, 2017 | Bard Access Systems StatLock PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 2 Terminated |
KMK | None listed |
| Jun 28, 2013 | Bard Access Systems StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock device provides stabilization for compatible medical tubes and catheters. Terminated |
KMK | None listed |
| Mar 15, 2007 | Merit Medical Systems, Inc EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain. Terminated |
KMK | None listed |
| Mar 15, 2007 | Merit Medical Systems, Inc StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Medical, Unomedical, Ltd., Great Britain. Terminated |
KMK | None listed |
| Mar 15, 2007 | Merit Medical Systems, Inc StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit Medical, Unomedical, Ltd., Great Britain. Terminated |
KMK | None listed |
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