FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL
K Number: K914523
·
Decision Jan 10, 1992
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
7
Applicant Total
8
Review Days
92
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Basic Information
- Device Name
- CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL
- K Number
- K914523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Catheter Research C/O Burditt, Bowles & Radzius
- Date Received
- October 10, 1991
- Decision Date
- January 10, 1992
- Product Code
- DSS
- 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 |
|---|---|---|---|
| DSS | Clip, Vascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSS), ordered by most recent decision date.
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SURGICAL SPRING CLIPS
FDA 510(k)
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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 |
| K904785 | CRI CYNOSAR CATHETER | Mar 6, 1991 | Substantially Equivalent |
| K904787 | CRI STEERABLE CATHETER CONTROL SYSTEM | Dec 17, 1990 | 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 |