K935461 is an FDA 510(k) clearance for the VECTOR AMBULATORY DRUG DELIVERY SYSTEM, a Pump, Infusion Or Syringe, Extra-luminal (Class II — Special Controls, product code FIH), submitted by Infusion Technology Intl. (Danvers, US). The FDA issued a Cleared decision on April 28, 1994, 167 days after receiving the submission on November 12, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K935461 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 12, 1993 |
| Decision Date | April 28, 1994 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIH — Pump, Infusion Or Syringe, Extra-luminal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |