FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PTA BALLOON CATHETER
K Number: K915349
·
Decision Feb 11, 1992
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
22
Review Days
77
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Basic Information
- Device Name
- PTA BALLOON CATHETER
- K Number
- K915349
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Schneider Intl., Ltd.
- Date Received
- November 26, 1991
- Decision Date
- February 11, 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 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 |
| K920157 | SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER | Mar 16, 1992 | Substantially Equivalent |
| K914009 | SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER | Dec 6, 1991 | Substantially Equivalent |