K945458 is an FDA 510(k) clearance for the VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM. This device is classified as a Tubes, Vacuum Sample, With Anticoagulant (Class II - Special Controls, product code GIM).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lake, US). The FDA issued a Cleared decision on February 6, 1995, 91 days after receiving the submission on November 7, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K945458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1994 |
| Decision Date | February 06, 1995 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | GIM — Tubes, Vacuum Sample, With Anticoagulant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |