FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.
K Number: K890492
·
Decision Mar 2, 1989
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
62
Applicant Total
15
Review Days
30
Basic Information
- Device Name
- PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.
- K Number
- K890492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2870
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- ENDOSONICS CORP.
- Date Received
- January 31, 1989
- Decision Date
- March 2, 1989
- Product Code
- DXO
- 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 |
|---|---|---|---|
| DXO | Transducer, Pressure, Catheter Tip | FDA class 2 | Cardiovascular |
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