FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER
K Number: K851848
·
Decision Jul 19, 1985
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
8
Review Days
84
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Basic Information
- Device Name
- PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER
- K Number
- K851848
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Mansfield Scientific, Inc.
- Date Received
- April 26, 1985
- Decision Date
- July 19, 1985
- 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 Mansfield Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K865017 | ANGIOSCOPE | Dec 15, 1987 | Substantially Equivalent |
| K870186 | ENDOMYOCARDIAL BIOPSY DEVICE | Feb 20, 1987 | Substantially Equivalent |
| K855103 | CIRIBART GYUDUBG CATGETER | Feb 18, 1986 | Substantially Equivalent |
| K853850 | EXPLORER | Dec 4, 1985 | Substantially Equivalent |
| K852797 | HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE | Sep 16, 1985 | Substantially Equivalent |
| K844752 | TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA | Jan 2, 1985 | Substantially Equivalent |
| K841705 | WEDGE PRESSURE CATHETER FLOW DIRECTED | Jul 13, 1984 | Substantially Equivalent |