510(k) K935461
K935461 is an FDA 510(k) premarket notification submitted by Infusion Technology Intl. for the device "VECTOR AMBULATORY DRUG DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 28, 1994. The device falls under product code FIH (Pump, Infusion Or Syringe, Extra-Luminal), a Class II device regulated under 21 CFR 876.5820. Infusion Technology Intl. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1994
- Date Received
- November 12, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion Or Syringe, Extra-Luminal
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type