K870770 is an FDA 510(k) clearance for the TIMLEINE(TM) VENIPUNCTURE SYSTEM. This device is classified as a Device, Intravascular Catheter Securement (Class I - General Controls, product code KMK).
Submitted by Ipax, Inc. (Englewood, US). The FDA issued a Cleared decision on April 23, 1987, 56 days after receiving the submission on February 26, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5210.
| 510(k) Number | K870770 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1987 |
| Decision Date | April 23, 1987 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | KMK - Device, Intravascular Catheter Securement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5210 |