FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROFLEX 5
K Number: K915168
·
Decision Feb 19, 1992
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
17
Review Days
96
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Basic Information
- Device Name
- PROFLEX 5
- K Number
- K915168
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Peripheral Systems Group
- Date Received
- November 15, 1991
- Decision Date
- February 19, 1992
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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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 |
| K913477 | APEX(TM) PROSTATIC BALLOON DILATION CATHETER | Dec 27, 1991 | Substantially Equivalent |
| K913746 | SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM | Dec 17, 1991 | Substantially Equivalent |
| K904984 | ADVANCE 418(TM) | Apr 12, 1991 | Substantially Equivalent |