FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRI STEERABLE CATHETER CONTROL SYSTEM
K Number: K904787
·
Decision Dec 17, 1990
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
32
Applicant Total
8
Review Days
55
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Basic Information
- Device Name
- CRI STEERABLE CATHETER CONTROL SYSTEM
- K Number
- K904787
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Catheter Research C/O Burditt, Bowles & Radzius
- Date Received
- October 23, 1990
- Decision Date
- December 17, 1990
- Product Code
- DXX
- 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 |
|---|---|---|---|
| DXX | System, Catheter Control, Steerable | FDA class 2 | Cardiovascular |
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Other Clearances by Catheter Research C/O Burditt, Bowles & Radzius
| K Number | Device Name | ||
|---|---|---|---|
| K924227 | CRI CYNOSAR CATHETER | Jun 29, 1993 | Substantially Equivalent |
| K924125 | CRI ELECTRONIC CONTROL SYSTEM | May 26, 1993 | Substantially Equivalent |
| K914523 | CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL | Jan 10, 1992 | Substantially Equivalent |
| K904785 | CRI CYNOSAR CATHETER | Mar 6, 1991 | Substantially Equivalent |
| K900320 | CRI CYNOSAR CATHETER | Sep 14, 1990 | Substantially Equivalent |
| K884337 | MICRO-GUIDE SYSTEM | Jan 5, 1989 | Substantially Equivalent |
| K870700 | MICRO-GUIDE | Dec 3, 1987 | Substantially Equivalent |