FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER
K Number: K920157
·
Decision Mar 16, 1992
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
22
Review Days
62
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Basic Information
- Device Name
- SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER
- K Number
- K920157
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Schneider Intl., Ltd.
- Date Received
- January 14, 1992
- Decision Date
- March 16, 1992
- Product Code
- DXY
- 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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | FDA class 3 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXY), ordered by most recent decision date.
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
FDA 510(k)
FDA Class 3
·Cardiovascular
OPUS S MODEL 4121 AND 4124 PACEMAKERS
FDA 510(k)
FDA Class 3
·Cardiovascular
PIKOS LP 01, PIKOS LP E01
FDA 510(k)
FDA Class 3
·Cardiovascular
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
FDA 510(k)
FDA Class 3
·Cardiovascular
Other Clearances by Schneider Intl., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K925406 | BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM | Jan 11, 1995 | Substantially Equivalent |
| K931577 | SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI | Jun 23, 1993 | Substantially Equivalent |
| K926271 | SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO | Jun 7, 1993 | Substantially Equivalent |
| K926003 | SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER | Jun 7, 1993 | Substantially Equivalent |
| K925804 | SCHNEIDER HYDRO-SIL GUIDEWIRE | Feb 12, 1993 | Substantially Equivalent |
| K924591 | SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER | Dec 8, 1992 | Substantially Equivalent |
| 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 |
| K915349 | PTA BALLOON CATHETER | Feb 11, 1992 | Substantially Equivalent |
| K914009 | SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER | Dec 6, 1991 | Substantially Equivalent |