FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCHNEIDER MAGNARAIL PROBING CATHETER
K Number: K910259
·
Decision Apr 18, 1991
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
22
Review Days
86
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Basic Information
- Device Name
- SCHNEIDER MAGNARAIL PROBING CATHETER
- K Number
- K910259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Schneider Intl., Ltd.
- Date Received
- January 22, 1991
- Decision Date
- April 18, 1991
- 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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|---|---|---|---|
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| K925804 | SCHNEIDER HYDRO-SIL GUIDEWIRE | Feb 12, 1993 | Substantially Equivalent |
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| K921856 | TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. | Jul 21, 1992 | Substantially Equivalent |
| K921943 | SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL | Jun 17, 1992 | Substantially Equivalent |
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