FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIKRO-TIP CATH. PRESSURE TRANSDUCER
K Number: K830909
·
Decision Apr 18, 1983
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
36
Applicant Total
18
Review Days
28
Basic Information
- Device Name
- MIKRO-TIP CATH. PRESSURE TRANSDUCER
- K Number
- K830909
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1915
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- MILLAR INSTRUMENTS, INC.
- Date Received
- March 21, 1983
- Decision Date
- April 18, 1983
- Product Code
- KRB
- 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 |
|---|---|---|---|
| KRB | Probe, Thermodilution | FDA class 2 | Cardiovascular |
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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 |
| K896264 | MILLAR MIKRO-TIP DOPPLER CATHETER | Jan 24, 1990 | 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 |