FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GYRO TIP EP CATHETER
K Number: K955847
·
Decision Jan 29, 1997
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
184
Applicant Total
3
Review Days
400
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Basic Information
- Device Name
- GYRO TIP EP CATHETER
- K Number
- K955847
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiac Assist Devices, Inc.
- Date Received
- December 26, 1995
- Decision Date
- January 29, 1997
- Product Code
- DRF
- 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 |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | FDA class 2 | Cardiovascular |
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