FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCU-FLUSH
K Number: K831637
·
Decision Jun 30, 1983
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
174
Applicant Total
4
Review Days
38
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
- ACCU-FLUSH
- K Number
- K831637
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Accu-Line
- Date Received
- May 23, 1983
- Decision Date
- June 30, 1983
- Product Code
- KRA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRA), ordered by most recent decision date.
Verge Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
TruSelect 2.6 Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
InVera Infusion Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
FDA 510(k)
FDA Class 2
·Cardiovascular
Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
FDA 510(k)
FDA Class 2
·Cardiovascular