Picc-Fix
FDA 510(k) K911070 · Sorex Medical
510(k) numberK911070
Submission
- Device name
- Picc-Fix
- Applicant
- Sorex Medical
Salt Lake City, UT, US - Received
- March 11, 1991
- Decision date
- July 5, 1991
- 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 |
|---|---|---|
| K923843 | FoglessOCT · Traditional | 03/25/1994SE |
| K913036 | Plume MasterFYD · Traditional | 09/06/1991SE |
| K911150 | Sorex Safe-AirGEX · Traditional | 06/28/1991SE |
| K910315 | Picc Insertion Kit/P.I.C. & Picc Exchang Kit/P.E.KLJS · Traditional | 04/05/1991SEKD |
| K905572 | Edlich Wound Management TrayMCY · Traditional | 03/12/1991SEKD |
| K903740 | Trach-EzeBSY · Traditional | 12/06/1990SE |
| K902410 | Medical Procedure TrayLDQ · Traditional | 11/20/1990SEKD |
| K885136 | Graft GuardLZM · Traditional | 02/06/1989SE |
Questions and answers
When was Picc-Fix cleared by the FDA?
Picc-Fix (K911070) received a 510(k) decision of Substantially Equivalent on July 5, 1991, 116 days after the submission was received.
What is the product code of K911070?
The FDA product code is KMK – Device, Intravascular Catheter Securement, a Class I (low risk) device regulated under 21 CFR 880.5210.