FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER
K Number: K915351
·
Decision Jun 29, 1992
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
21
Review Days
216
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Basic Information
- Device Name
- SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER
- K Number
- K915351
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medtronics Interventional Vascular
- Date Received
- November 26, 1991
- Decision Date
- June 29, 1992
- 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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| K972944 | MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT | Nov 3, 1997 | Substantially Equivalent |
| K961917 | MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) | Nov 20, 1996 | Substantially Equivalent |
| K960983 | MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT | May 30, 1996 | Substantially Equivalent |
| K955651 | MEDTRONIC SHERPA GUIDING CATHETER | Jan 22, 1996 | Substantially Equivalent |
| K950490 | MEDTRONIC GC IV CORONARY GUIDING CATHETER | Nov 21, 1995 | Substantially Equivalent |
| K950179 | MEDTRONIC(R) GC III CORONARY GUIDING CATHETER | Jul 25, 1995 | Substantially Equivalent |