FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLUSHFLO II
K Number: K812173
·
Decision Aug 18, 1981
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
174
Applicant Total
55
Review Days
15
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
- FLUSHFLO II
- K Number
- K812173
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Bentley Laboratories, Inc.
- Date Received
- August 3, 1981
- Decision Date
- August 18, 1981
- 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
Other Clearances by Bentley Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931967 | HE-30 GOLD | Jul 13, 1993 | Substantially Equivalent |
| K913956 | BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 | Jan 17, 1992 | Substantially Equivalent |
| K913692 | VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) | Nov 15, 1991 | Substantially Equivalent |
| K903641 | QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q | Nov 9, 1990 | Substantially Equivalent |
| K894826 | UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF | Feb 28, 1990 | Substantially Equivalent |
| K874841 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | Feb 2, 1988 | Substantially Equivalent |
| K874867 | CATR(TM)-H CARDIOTOMY HOLDER | Feb 2, 1988 | Substantially Equivalent |
| K874618 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER | Jan 19, 1988 | Substantially Equivalent |
| K823273 | BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. | Jan 5, 1983 | Substantially Equivalent |
| K823359 | OXYGEN CONSUMPTION MONITOR #OCM-0100 | Jan 5, 1983 | Substantially Equivalent |