Product code KMK
- Device name
- Device, Intravascular Catheter Securement
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.5210
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F | Interrad Medical, Inc. | 2019-07-09 |
| K981860 | A P HARNESS | Paraworks Enterprise, Ltd. | 1999-06-03 |
| K963365 | MULTI-PURPOSE MEDICAL TUBE HOLDER | Byrd Medical Devices, Inc. | 1996-10-11 |
| K941098 | SECURE-SITE | Op-Co Medical Products , Ltd. | 1995-08-09 |
| K943147 | STATLOCK CV | Venetec, Inc. | 1994-09-29 |
| K943047 | IV START KITS | Sterile Concepts, Inc. | 1994-09-14 |
| K941940 | IMMOBILE STERILE AND IMMOBILE A/C STERILE | Tnt Moborg Intl. , Ltd. | 1994-07-14 |
| K941850 | IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE | Tnt Moborg Intl. , Ltd. | 1994-07-14 |
| K935389 | CONMED VENI-GARD I.V. DRESSING | Conmedcorp | 1994-03-07 |
| K935252 | K-LOK CATHETER SECUREMENT DEVICE MODIFICATION | K-Lok, Inc. | 1994-02-18 |
| K940127 | CENTERMARK SECURING WINGS | Menlo Care, Inc. | 1994-02-09 |
| K932757 | SECURODRIP (TM) I.V. ARMBOARD | Op-Co Medical Products , Ltd. | 1993-12-08 |
| K925992 | DUODERM TRANSPARENT HYDROCOLLOID DRESSING | Convatec, A Division of E.R. Squibb & Sons | 1993-10-15 |
| K930663 | IV COMFORT PAD | D.J. Scott Mfg., Inc. | 1993-09-30 |
| K922103 | IAB ANCHOR | Datascope Corp. | 1993-08-03 |
| K930225 | K-LOK CATHETER SECUREMENT DEVICE | K-Lok, Inc. | 1993-04-21 |
| K930197 | KWIK BOARD | Astral, Ltd. | 1993-04-20 |
| K924180 | I.V. PRO | I.V. - Pro Tek, Inc. | 1993-03-16 |
| K924369 | ILS(TM) - INVASIVE LINE SEPARATOR | 2-Rn Corp. | 1993-02-05 |
| K924249 | DERMASSIST TRANSPARENT SITE DRESSING | Wilshire Medical Products | 1993-02-03 |
| K925502 | TRACE MODEL# 840, 841,842 & 845 ARM BOARD | Trace Medical Equipment, Inc. | 1993-01-12 |
| K924568 | TUBE, LEAD, AND CORD HOLDER NO. 102 | Ansley Medical Products, Inc. | 1992-11-23 |
| K924567 | FOLEY CATHETER TUBE HOLDER NO. 101 | Ansley Medical Products, Inc. | 1992-11-23 |
| K924566 | RESTRAINT, PROTECTIVE N0. 103 | Ansley Medical Products, Inc. | 1992-11-23 |
| K915495 | DESERET POSITIONAL SUTURE WING | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-04-06 |
| K912660 | SECURODRIP | Op-Co Medical Products , Ltd. | 1991-12-04 |
| K912942 | IV HOUSE | Progressive Iv'S, Inc. | 1991-09-25 |
| K912211 | INTRAVASCULAR CATHETER SECURMENT DEVICE | Inman Liebelt Corp. | 1991-08-09 |
| K911070 | PICC-FIX | Sorex Medical | 1991-07-05 |
| K910880 | COMFOR-BOARD | Medway | 1991-06-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10618125192585 | Grip-Lok | TIDI PRODUCTS, LLC | 2026-04-15 |
| 10618125192141 | Grip-Lok | TIDI PRODUCTS, LLC | 2024-12-02 |
| 10618125135148 | Grip-Lok | TIDI PRODUCTS, LLC | 2024-04-22 |
| 08800125000006 | SDFIX | DFIX | 2023-01-27 |
| 10634624100616 | Tie-V Securement Device | QUEST MEDICAL INC | 2022-12-15 |
| 10618125134707 | Grip-Lok | TIDI PRODUCTS, LLC | 2022-10-12 |
| 10618125134714 | Grip-Lok | TIDI PRODUCTS, LLC | 2022-10-12 |
| 10618125134769 | Grip-Lok | TIDI PRODUCTS, LLC | 2022-10-12 |
| 10653160267270 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 10653160246589 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 10653160267294 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 10653160270201 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 10653160270218 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 10653160270256 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 10653160270263 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 10653160270348 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 10653160270386 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 10653160270393 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 10653160262756 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
| 10653160258063 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
| 10653160250005 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
| 10653160270164 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
| 10653160270171 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
| 10653160246305 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
| 10653160241010 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
| 10193489194890 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-23 |
| 08711428085273 | 3M™ Tegaderm™ | 3M COMPANY | 2018-09-24 |
| 08717648149597 | MITRACLIP | ABBOTT VASCULAR INC. | 2017-06-12 |
| 08717648149580 | MITRACLIP | ABBOTT VASCULAR INC. | 2017-06-12 |
| 08717648149573 | MITRACLIP | ABBOTT VASCULAR INC. | 2017-06-12 |