FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIKRO-TIP ANGIOGRAPHIC CATHETER
K Number: K952773
·
Decision Nov 7, 1995
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
18
Review Days
144
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Basic Information
- Device Name
- MIKRO-TIP ANGIOGRAPHIC CATHETER
- K Number
- K952773
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Millar Instruments, Inc.
- Date Received
- June 16, 1995
- Decision Date
- November 7, 1995
- Product Code
- DQO
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
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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 |
| 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 |
| K860766 | MILLAR PULSED DOPPLER VELOCIMETER | Jul 29, 1986 | Substantially Equivalent |