K981860 is an FDA 510(k) clearance for the A P HARNESS. This device is classified as a Device, Intravascular Catheter Securement (Class I - General Controls, product code KMK).
Submitted by Paraworks Enterprise, Ltd. (Vancouver, British Columbia, CA). The FDA issued a Cleared decision on June 3, 1999, 372 days after receiving the submission on May 27, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5210.
| 510(k) Number | K981860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 1998 |
| Decision Date | June 03, 1999 |
| Days to Decision | 372 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KMK — Device, Intravascular Catheter Securement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5210 |