FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MILLAR MIKRO-TIP DOPPLER CATHETER
K Number: K896264
·
Decision Jan 24, 1990
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
71
Applicant Total
18
Review Days
85
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
- MILLAR MIKRO-TIP DOPPLER CATHETER
- K Number
- K896264
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2880
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Millar Instruments, Inc.
- Date Received
- October 31, 1989
- Decision Date
- January 24, 1990
- Product Code
- JOP
- 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 |
|---|---|---|---|
| JOP | Transducer, Ultrasonic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOP), ordered by most recent decision date.
Falcon/Xpress (Falcon/Xpress)
FDA 510(k)
FDA Class 2
·Cardiovascular
VasoGuard (V10, V8, V6, V4, V2)
FDA 510(k)
FDA Class 2
·Cardiovascular
Smartdop XT6
FDA 510(k)
FDA Class 2
·Cardiovascular
SMARTDOP XT
FDA 510(k)
FDA Class 2
·Cardiovascular
VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING
FDA 510(k)
FDA Class 2
·Cardiovascular
FALCON
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Millar Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K112323 | CARDIA-CATH | Oct 18, 2011 | Substantially Equivalent |
| K093111 | MIKRO-CATH, MODEL 825-0101 | Jan 5, 2010 | Substantially Equivalent |
| K013205 | MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 | Jul 2, 2002 | Substantially Equivalent |
| K993694 | MIKRO-TIP ANGIOGRAPHIC CATHETER | Mar 1, 2000 | Substantially Equivalent |
| K952773 | MIKRO-TIP ANGIOGRAPHIC CATHETER | Nov 7, 1995 | Substantially Equivalent |
| K935166 | FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER | Aug 5, 1994 | Substantially Equivalent |
| K915775 | MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN | Apr 20, 1992 | Substantially Equivalent |
| K895721 | MILLAR MIKRO-TIP PULSE TRANSDUCER | Dec 7, 1989 | Substantially Equivalent |
| K883651 | MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER | Nov 18, 1988 | Substantially Equivalent |
| K860766 | MILLAR PULSED DOPPLER VELOCIMETER | Jul 29, 1986 | Substantially Equivalent |