FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CANYONS BI-DIRECTIONAL CHECK VALVE
K Number: K954181
·
Decision Nov 29, 1995
Classifications
1
FEI Numbers
275
Registration Numbers
276
Same Product Code
10
Applicant Total
3
Review Days
84
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CANYONS BI-DIRECTIONAL CHECK VALVE
- K Number
- K954181
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6430
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Canyon Medical Products
- Date Received
- September 6, 1995
- Decision Date
- November 29, 1995
- Product Code
- KYX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KYX | Dispenser, Liquid Medication | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KYX), ordered by most recent decision date.
KleenGel Dispenser
FDA 510(k)
FDA Class 1
·General Hospital
CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER
FDA 510(k)
FDA Class 1
·General Hospital
BOTTLE ADAPTER
FDA 510(k)
FDA Class 1
·General Hospital
MULTI-AD FLUID DISPENSING PUMP MP-3000
FDA 510(k)
FDA Class 1
·General Hospital
SYRINGE TIP CONNECTOR
FDA 510(k)
FDA Class 1
·General Hospital
FLUID DISPENSING SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital