FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOMYOCARDIAL BIOPSY DEVICE
K Number: K870186
·
Decision Feb 20, 1987
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
22
Applicant Total
8
Review Days
35
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Basic Information
- Device Name
- ENDOMYOCARDIAL BIOPSY DEVICE
- K Number
- K870186
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4075
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Mansfield Scientific, Inc.
- Date Received
- January 16, 1987
- Decision Date
- February 20, 1987
- Product Code
- DWZ
- 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 |
|---|---|---|---|
| DWZ | Device, Biopsy, Endomyocardial | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K853850 | EXPLORER | Dec 4, 1985 | Substantially Equivalent |
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| K851848 | PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER | Jul 19, 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 |