FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GUIDING CATHETERS 9F JL4
K Number: K871021
·
Decision Jun 16, 1987
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
14
Review Days
92
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Basic Information
- Device Name
- GUIDING CATHETERS 9F JL4
- K Number
- K871021
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Devices For Vascular Intervention, Inc.
- Date Received
- March 16, 1987
- Decision Date
- June 16, 1987
- 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 Devices For Vascular Intervention, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935929 | MICROTRACK | Mar 10, 1994 | Substantially Equivalent |
| K920707 | HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER | Nov 23, 1992 | Substantially Equivalent |
| K914422 | DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE | Dec 18, 1991 | Substantially Equivalent |
| K911678 | ROTATING HEMOSTATIC VALVE | Jul 12, 1991 | Substantially Equivalent |
| K910205 | LP-60 LOW PRESSURE INFLATION DEVICE | Feb 25, 1991 | Substantially Equivalent |
| K901601 | HOLLOW MOTOR DRIVE UNIT | Jul 6, 1990 | Substantially Equivalent |
| K883933 | INTRODUCING CATHETER | Dec 2, 1988 | Substantially Equivalent |
| K883981 | GUIDING CATHETER (TIP SOFTNESS CHANGE) | Nov 3, 1988 | Substantially Equivalent |
| K883916 | ROTATING HEMOSTATIC VALVE | Oct 28, 1988 | Substantially Equivalent |
| K883346 | SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F | Sep 26, 1988 | Substantially Equivalent |