FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WEDGE PRESSURE CATHETER FLOW DIRECTED
K Number: K841705
·
Decision Jul 13, 1984
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
98
Applicant Total
8
Review Days
81
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Basic Information
- Device Name
- WEDGE PRESSURE CATHETER FLOW DIRECTED
- K Number
- K841705
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Mansfield Scientific, Inc.
- Date Received
- April 23, 1984
- Decision Date
- July 13, 1984
- Product Code
- DYG
- 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 |
|---|---|---|---|
| DYG | Catheter, Flow Directed | 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 |
| K851848 | PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER | Jul 19, 1985 | Substantially Equivalent |
| K844752 | TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA | Jan 2, 1985 | Substantially Equivalent |