Device, Intravascular Catheter Securement
FDA product code KMK · Class I (low risk) · 21 CFR 880.5210 · General Hospital
64510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Op-Co Medical Products , Ltd. 3
- Ansley Medical Products, Inc. 3
- Dale Medical Products, Inc. 2
- Vitaphore Corp. 2
- Consolidated Medical Equipment, Inc. 2
- K-Lok, Inc. 2
- Tnt Moborg Intl. , Ltd. 2
- Saxnor Corp. 2
- Hpd Medical, Inc. 1
- Turn Needle Intl., Inc. 1
- Orange Medical Instruments, Inc. 1
- Tapemark Co. 1
- Fpp, Inc. 1
- Ray-Marshall Laboratory 1
- Jelco Laboratories 1
- Georgetown Medical Co. 1
- Pan-Tech Research, Inc. 1
- Johnson & Johnson Professionals, Inc. 1
- Eyevi & Co. 1
- Interrad Medical, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath…KMK · Traditional | Interrad Medical, Inc. | 07/09/2019SE |
| K981860 | A P HarnessKMK · Traditional | Paraworks Enterprise, Ltd. | 06/03/1999SE |
| K963365 | Multi-Purpose Medical Tube HolderKMK · Traditional | Byrd Medical Devices, Inc. | 10/11/1996SE |
| K941098 | Secure-SiteKMK · Traditional | Op-Co Medical Products , Ltd. | 08/09/1995SE |
| K943147 | Statlock CVKMK · Traditional | Venetec, Inc. | 09/29/1994SE |
| K943047 | IV Start KitsKMK · Traditional | Sterile Concepts, Inc. | 09/14/1994SE |
| K941940 | Immobile Sterile and Immobile A/C SterileKMK · Traditional | Tnt Moborg Intl. , Ltd. | 07/14/1994SE |
| K941850 | Immobile Non-Sterile and Immobile A/C Non-SterileKMK · Traditional | Tnt Moborg Intl. , Ltd. | 07/14/1994SE |
| K935389 | Conmed Veni-Gard I.V. DressingKMK · Traditional | Conmedcorp | 03/07/1994SE |
| K935252 | K-Lok Catheter Securement Device ModificationKMK · Traditional | K-Lok, Inc. | 02/18/1994SE |
| K940127 | Centermark Securing WingsKMK · Traditional | Menlo Care, Inc. | 02/09/1994SE |
| K932757 | Securodrip (TM) I.V. ArmboardKMK · Traditional | Op-Co Medical Products , Ltd. | 12/08/1993SE |
| K925992 | Duoderm Transparent Hydrocolloid DressingKMK · Traditional | Convatec, A Division of E.R. Squibb & Sons | 10/15/1993SE |
| K930663 | IV Comfort PadKMK · Traditional | D.J. Scott Mfg., Inc. | 09/30/1993SE |
| K922103 | Iab AnchorKMK · Traditional | Datascope Corp. | 08/03/1993SE |
| K930225 | K-Lok Catheter Securement DeviceKMK · Traditional | K-Lok, Inc. | 04/21/1993SE |
| K930197 | Kwik BoardKMK · Traditional | Astral, Ltd. | 04/20/1993SE |
| K924180 | I.V. ProKMK · Traditional | I.V. - Pro Tek, Inc. | 03/16/1993SE |
| K924369 | Ils(Tm) - Invasive Line SeparatorKMK · Traditional | 2-Rn Corp. | 02/05/1993SE |
| K924249 | Dermassist Transparent Site DressingKMK · Traditional | Wilshire Medical Products | 02/03/1993SE |
| K925502 | Trace Model# 840, 841,842 & 845 Arm BoardKMK · Traditional | Trace Medical Equipment, Inc. | 01/12/1993SE |
| K924568 | Tube, Lead, and Cord Holder No. 102KMK · Traditional | Ansley Medical Products, Inc. | 11/23/1992SE |
| K924567 | Foley Catheter Tube Holder No. 101KMK · Traditional | Ansley Medical Products, Inc. | 11/23/1992SE |
| K924566 | Restraint, Protective N0. 103KMK · Traditional | Ansley Medical Products, Inc. | 11/23/1992SE |
| K915495 | Deseret Positional Suture WingKMK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/06/1992SE |
| K912660 | SecurodripKMK · Traditional | Op-Co Medical Products , Ltd. | 12/04/1991SE |
| K912942 | IV HouseKMK · Traditional | Progressive Iv'S, Inc. | 09/25/1991SE |
| K912211 | Intravascular Catheter Securment DeviceKMK · Traditional | Inman Liebelt Corp. | 08/09/1991SE |
| K911070 | Picc-FixKMK · Traditional | Sorex Medical | 07/05/1991SE |
| K910880 | Comfor-BoardKMK · Traditional | Medway | 06/06/1991SE |
| K905735 | Genny Denny IV ShieldKMK · Traditional | Tadco, Inc. | 01/18/1991SE |
| K900134 | Baby Boards IV Support AssemblyKMK · Traditional | Baby Boards, Inc. | 07/09/1990SE |
| K896421 | Transparent Film I.V. Site/Wound DressingKMK · Traditional | Catalina Biomedical Corp. | 01/31/1990SE |
| K896046 | Vitapatch Cath. Securement Device W/ChlorhexidineKMK · Traditional | Vitaphore Corp. | 01/11/1990SE |
| K895993 | Vitapatch Antimicrobial Catheter Securement DeviceKMK · Traditional | Vitaphore Corp. | 01/11/1990SE |
| K895431 | Johnson & Johnson Tube Securement DeviceKMK · Traditional | Johnson & Johnson Patient Care, Inc. | 10/13/1989SE |
| K894586 | Dale I.V. Identifier; Product #1125KMK · Traditional | Dale Medical Products, Inc. | 08/15/1989SE |
| K873311 | Dale I.V. Connect. Lock & Stabilizer (STABILOK)220KMK · Traditional | Dale Medical Products, Inc. | 11/05/1987SE |
| K870770 | Timleine(Tm) Venipuncture SystemKMK · Traditional | Ipax, Inc. | 04/23/1987SE |
| K864190 | E-Z Hold - #4060KMK · Traditional | John F. Greer Co., Inc. | 01/14/1987SE |
| K860706 | IV Band (Intravenous Catheter Assesory)KMK · Traditional | T. G. & E. Medical | 03/21/1986SE |
| K860071 | Hold-It Framed Adhesive FilmKMK · Traditional | Vlv Associates, Inc. | 01/27/1986SE |
| K854040 | I.V. DressingKMK · Traditional | Consolidated Medical Equipment, Inc. | 01/09/1986SE |
| K853418 | Safti-BraceletKMK · Traditional | Advanced Biosearch Assn. | 09/20/1985SE |
| K850503 | Secu-Tape Universal Flexible Medical ClampsKMK · Traditional | Turn Needle Intl., Inc. | 04/01/1985SE |
| K843882 | Trends LancetKMK · Traditional | Orange Medical Instruments, Inc. | 11/05/1984SE |
| K842999 | Veni-ShieldKMK · Traditional | U.S. Mfg. & Management, Inc. | 09/24/1984SE |
| K842064 | Acu-Derm Transparent IV DressingKMK · Traditional | Acme United Corp. | 08/15/1984SE |
| K841487 | Intravascular Catheter Securement DevKMK · Traditional | Tapemark Co. | 06/28/1984SE |
| K840683 | FPP IV SecureKMK · Traditional | Fpp, Inc. | 03/06/1984SE |
| K832300 | I.V. Filter HolderKMK · Traditional | Saxnor Corp. | 10/04/1983SE |
| K830300 | Frehan Inc. I.V. Filter HolderKMK · Traditional | Saxnor Corp. | 03/01/1983SE |
| K822732 | Lineguard Catheter Shield Model 100KMK · Traditional | Ray-Marshall Laboratory | 09/24/1982SE |
| K821957 | Cath-LokKMK · Traditional | Hpd Medical, Inc. | 07/28/1982SE |
| K821796 | Ez-Fix I.V. Catheter HolderKMK · Traditional | Dyna Care | 06/24/1982SE |
| K821317 | Universal I.V. HolderKMK · Traditional | Georgetown Medical Co. | 05/28/1982SE |
| K820759 | Vein-ShieldKMK · Traditional | Pan-Tech Research, Inc. | 05/14/1982SE |
| K812080 | Aegis I.V. StripsKMK · Traditional | Warner-Lambert Co. | 08/03/1981SE |
| K810579 | Adhesive I.V. Catheter DressingKMK · Traditional | Johnson & Johnson Professionals, Inc. | 03/26/1981SE |
| K800726 | Eyewi AnkorsKMK · Traditional | Eyevi & Co. | 05/08/1980SE |
| K800024 | I.V. Tape Down HolderKMK · Traditional | Consolidated Medical Equipment, Inc. | 01/29/1980SE |
| K792049 | I.V. StripKMK · Traditional | E-Med Corp. | 11/20/1979SE |
| K781800 | Grip, Hospital UtilityKMK · Traditional | Baka Manufacturing Co., Inc. | 12/07/1978SE |
| K770119 | I.V. Lok TMKMK · Traditional | Jelco Laboratories | 03/14/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2120-2017 Class II | StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile.…StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip. | Bard Access Systems Inc. | 04/25/2017Terminated |
| Z-0982-2017 Class II | StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit…Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices… | Bard Access Systems | 12/09/2016Terminated |
| Z-0981-2017 Class II | StatLock PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single…Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices… | Bard Access Systems | 12/09/2016Terminated |
| Z-1618-2013 Class II | StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only…BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to… | Bard Access Systems | 06/10/2013Terminated |
| Z-0629-2007 | EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.Sterility of some units may be compromised due to damaged packaging. | Merit Medical Systems, Inc | 02/15/2007Terminated |
| Z-0628-2007 | StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit…Sterility of some units may be compromised due to damaged packaging. | Merit Medical Systems, Inc | 02/15/2007Terminated |
| Z-0627-2007 | StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit…Sterility of some units may be compromised due to damaged packaging. | Merit Medical Systems, Inc | 02/15/2007Terminated |