Vitapatch Cath. Securement Device W/Chlorhexidine
FDA 510(k) K896046 · Vitaphore Corp.
510(k) numberK896046
Submission
- Device name
- Vitapatch Cath. Securement Device W/Chlorhexidine
- Applicant
- Vitaphore Corp.
Menlo Park, CA, US - Received
- October 17, 1989
- Decision date
- January 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KMK – Device, Intravascular Catheter Securement
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5210
- Specialty
- General Hospital
Other 510(k)s with product code KMK
| 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 |
More from K-Lok, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K914579 | Silver Foam Wound DressingFRO · Traditional | 02/21/1992SE |
| K913148 | Collagen Shield for Acute CareMOE · Traditional | 10/15/1991SE |
| K895920 | Vitapatch Pin Protection Device for PercutaneousKGX · Traditional | 06/06/1991SE |
| K902558 | Collagen Shield for Acute CareMOE · Traditional | 08/17/1990SE |
| K891993 | Collagen NeurospongeHBA · Traditional | 03/23/1990SE |
| K896455 | Vitachoice Wound DressingKGX · Traditional | 02/15/1990SE |
| K895993 | Vitapatch Antimicrobial Catheter Securement DeviceKMK · Traditional | 01/11/1990SE |
| K890435 | Vitaaccess Catheter Introducer KitFOZ · Traditional | 03/29/1989SESD |
| K882100 | Vitacuff(R) Percutaneous Infect. Control KitLJS · Traditional | 07/13/1988SE |
| K872998 | Vitaaccess (TM) Catheter Introducer SystemFOZ · Traditional | 03/24/1988SE |
Questions and answers
When was Vitapatch Cath. Securement Device W/Chlorhexidine cleared by the FDA?
Vitapatch Cath. Securement Device W/Chlorhexidine (K896046) received a 510(k) decision of Substantially Equivalent on January 11, 1990, 86 days after the submission was received.
What is the product code of K896046?
The FDA product code is KMK – Device, Intravascular Catheter Securement, a Class I (low risk) device regulated under 21 CFR 880.5210.