K920635 is an FDA 510(k) clearance for the E-Z SET/MINICATH INFUSION SETS. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sandy, US). The FDA issued a Cleared decision on April 6, 1992, 54 days after receiving the submission on February 12, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K920635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 1992 |
| Decision Date | April 06, 1992 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |