K943591 is an FDA 510(k) clearance for the VECTOR(TM) AMBULATORY DRUG DELIVERY SYSTEM. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Infusion Technology Intl. (Danvers, US). The FDA issued a Cleared decision on June 28, 1995, 338 days after receiving the submission on July 25, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K943591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1994 |
| Decision Date | June 28, 1995 |
| Days to Decision | 338 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |