KMK · Device, Intravascular Catheter Securement
General Hospital · 21 CFR 880.5210 · Class 1
Overview
| Product Code | KMK |
|---|---|
| Device Name | Device, Intravascular Catheter Securement |
| Regulation | 21 CFR 880.5210 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (20 of 64)
Showing 20 most recent of 64 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F | Interrad Medical, Inc. | Jul 9, 2019 | SESE |
| K981860 | A P HARNESS | Paraworks Enterprise, Ltd. | Jun 3, 1999 | SESE |
| K963365 | MULTI-PURPOSE MEDICAL TUBE HOLDER | Byrd Medical Devices, Inc. | Oct 11, 1996 | SESE |
| K941098 | SECURE-SITE | Op-Co Medical Products , Ltd. | Aug 9, 1995 | SESE |
| K943147 | STATLOCK CV | Venetec, Inc. | Sep 29, 1994 | SESE |
| K943047 | IV START KITS | Sterile Concepts, Inc. | Sep 14, 1994 | SESE |
| K941940 | IMMOBILE STERILE AND IMMOBILE A/C STERILE | Tnt Moborg Intl. , Ltd. | Jul 14, 1994 | SESE |
| K941850 | IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE | Tnt Moborg Intl. , Ltd. | Jul 14, 1994 | SESE |
| K935389 | CONMED VENI-GARD I.V. DRESSING | Conmedcorp | Mar 7, 1994 | SESE |
| K935252 | K-LOK CATHETER SECUREMENT DEVICE MODIFICATION | K-Lok, Inc. | Feb 18, 1994 | SESE |
| K940127 | CENTERMARK SECURING WINGS | Menlo Care, Inc. | Feb 9, 1994 | SESE |
| K932757 | SECURODRIP (TM) I.V. ARMBOARD | Op-Co Medical Products , Ltd. | Dec 8, 1993 | SESE |
| K925992 | DUODERM TRANSPARENT HYDROCOLLOID DRESSING | Convatec, A Division of E.R. Squibb & Sons | Oct 15, 1993 | SESE |
| K930663 | IV COMFORT PAD | D.J. Scott Mfg., Inc. | Sep 30, 1993 | SESE |
| K922103 | IAB ANCHOR | Datascope Corp. | Aug 3, 1993 | SESE |
| K930225 | K-LOK CATHETER SECUREMENT DEVICE | K-Lok, Inc. | Apr 21, 1993 | SESE |
| K930197 | KWIK BOARD | Astral, Ltd. | Apr 20, 1993 | SESE |
| K924180 | I.V. PRO | I.V. - Pro Tek, Inc. | Mar 16, 1993 | SESE |
| K924369 | ILS(TM) - INVASIVE LINE SEPARATOR | 2-Rn Corp. | Feb 5, 1993 | SESE |
| K924249 | DERMASSIST TRANSPARENT SITE DRESSING | Wilshire Medical Products | Feb 3, 1993 | SESE |
Top Applicants
- Ansley Medical Products, Inc. — 3 clearances
- Op-Co Medical Products , Ltd. — 3 clearances
- Consolidated Medical Equipment, Inc. — 2 clearances
- Dale Medical Products, Inc. — 2 clearances
- K-Lok, Inc. — 2 clearances
