FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIUS NEXT GENERATION GUIDEWIRE
K Number: K011759
·
Decision Aug 23, 2001
Classifications
1
FEI Numbers
91
Registration Numbers
91
Same Product Code
42
Applicant Total
9
Review Days
78
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Basic Information
- Device Name
- RADIUS NEXT GENERATION GUIDEWIRE
- K Number
- K011759
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radius Medical Technologies, Inc.
- Date Received
- June 6, 2001
- Decision Date
- August 23, 2001
- Product Code
- OCY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Radius Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070502 | RADIUS SNARE | Oct 4, 2007 | Substantially Equivalent |
| K071457 | MODIFICATION TO RADIUS SNARE | Sep 25, 2007 | Substantially Equivalent |
| K032899 | RADIUS COUGAR WIRE | Oct 17, 2003 | Substantially Equivalent |
| K032129 | RADIUS 018 COUGAR WIRE | Jul 17, 2003 | Substantially Equivalent |
| K022201 | RADIUS MICRO SNARE | Feb 3, 2003 | Substantially Equivalent |
| K021441 | RADIUS SNARE | Jun 14, 2002 | Substantially Equivalent |
| K011287 | RADIUS COUGAR WIRE | May 25, 2001 | Substantially Equivalent |
| K970466 | RADIUS PTCA GUIDEWIRE | May 20, 1997 | Substantially Equivalent |