KMK — Device, Intravascular Catheter Securement Class I
FDA product code KMK covers "Device, Intravascular Catheter Securement", a Class I medical device regulated under 21 CFR 880.5210. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KMK
- Device Class
- Class I
- Regulation Number
- 880.5210
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K180994 | interrad medical | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, Sec | July 9, 2019 |
| K981860 | paraworks enterprise | A P HARNESS | June 3, 1999 |
| K963365 | byrd medical devices | MULTI-PURPOSE MEDICAL TUBE HOLDER | October 11, 1996 |
| K941098 | op-co medical products | SECURE-SITE | August 9, 1995 |
| K943147 | venetec | STATLOCK CV | September 29, 1994 |
| K943047 | sterile concepts | IV START KITS | September 14, 1994 |
| K941940 | tnt moborg intl. | IMMOBILE STERILE AND IMMOBILE A/C STERILE | July 14, 1994 |
| K941850 | tnt moborg intl. | IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE | July 14, 1994 |
| K935389 | conmedcorp | CONMED VENI-GARD I.V. DRESSING | March 7, 1994 |
| K935252 | k-lok | K-LOK CATHETER SECUREMENT DEVICE MODIFICATION | February 18, 1994 |
| K940127 | menlo care | CENTERMARK SECURING WINGS | February 9, 1994 |
| K932757 | op-co medical products | SECURODRIP (TM) I.V. ARMBOARD | December 8, 1993 |
| K925992 | convatec, a division of e.r. squibb and sons | DUODERM TRANSPARENT HYDROCOLLOID DRESSING | October 15, 1993 |
| K930663 | d.j. scott mfg | IV COMFORT PAD | September 30, 1993 |
| K922103 | datascope | IAB ANCHOR | August 3, 1993 |
| K930225 | k-lok | K-LOK CATHETER SECUREMENT DEVICE | April 21, 1993 |
| K930197 | astral | KWIK BOARD | April 20, 1993 |
| K924180 | i.v. - pro tek | I.V. PRO | March 16, 1993 |
| K924369 | 2-rn | ILS(TM) - INVASIVE LINE SEPARATOR | February 5, 1993 |
| K924249 | wilshire medical products | DERMASSIST TRANSPARENT SITE DRESSING | February 3, 1993 |