FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PSG HEMOSTATIC CONTROL VALVE
K Number: K904959
·
Decision Dec 17, 1990
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
17
Review Days
42
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Basic Information
- Device Name
- PSG HEMOSTATIC CONTROL VALVE
- K Number
- K904959
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Peripheral Systems Group
- Date Received
- November 5, 1990
- Decision Date
- December 17, 1990
- 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 Peripheral Systems Group
| K Number | Device Name | ||
|---|---|---|---|
| K940804 | SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION | Jun 10, 1994 | Substantially Equivalent |
| K934433 | VANTAGE DIALTAION CATHETER | Dec 9, 1993 | Substantially Equivalent |
| K932777 | SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER | Oct 7, 1993 | Substantially Equivalent |
| K931327 | PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE | Jul 14, 1993 | Substantially Equivalent |
| K915554 | HI-TORQUE SPORT-T(TM) GUIDE WIRE | Feb 9, 1993 | Substantially Equivalent |
| K914979 | EDM(R) INFUSION CATHETER | Sep 16, 1992 | Substantially Equivalent |
| K913941 | PSG(TM) 20 GUAGE DOPPLER NEEDLE | Feb 27, 1992 | Substantially Equivalent |
| K915168 | PROFLEX 5 | Feb 19, 1992 | Substantially Equivalent |
| K913477 | APEX(TM) PROSTATIC BALLOON DILATION CATHETER | Dec 27, 1991 | Substantially Equivalent |
| K913746 | SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM | Dec 17, 1991 | Substantially Equivalent |