510(k) K935461
- Device
- Vector Ambulatory Drug Delivery System
- Applicant
- INFUSION TECHNOLOGY INTL.
- 510(k) number
- K935461
- Product code
- FIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-04-28
- Date received
- 1993-11-12
- Regulation
- 876.5820
- Classification name
- Pump, Infusion Or Syringe, Extra-Luminal
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL FENTON
- Address
- 35 Cherry Hill Dr. Danvers MA US 01923 01923
FDA Registration Numbers#
- 3004753774
- 3012044688
Source Documents#
Other 510(k) Records For Product Code FIH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K932055 | PERCUPUMP II | E-Z-Em, Inc. | 1995-03-21 |
| K931113 | CADD-TPN(TM) AMBULATORY INFUSION SYSTEM | Pharmacia Deltec, Inc. | 1994-04-28 |
| K900439 | SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC | L H M Ent., Inc. | 1990-02-15 |
| K881707 | INTROCULAR FLUID INJECTOR | B&B Medical Assoc., Inc. | 1988-10-21 |