FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO RADIUS SNARE
K Number: K071457
·
Decision Sep 25, 2007
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
31
Applicant Total
9
Review Days
123
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Basic Information
- Device Name
- MODIFICATION TO RADIUS SNARE
- K Number
- K071457
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radius Medical Technologies, Inc.
- Date Received
- May 25, 2007
- Decision Date
- September 25, 2007
- Product Code
- MMX
- 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 |
|---|---|---|---|
| MMX | Device, Percutaneous Retrieval | FDA class 2 | Cardiovascular |
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Other Clearances by Radius Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070502 | RADIUS SNARE | Oct 4, 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 |
| K011759 | RADIUS NEXT GENERATION GUIDEWIRE | Aug 23, 2001 | Substantially Equivalent |
| K011287 | RADIUS COUGAR WIRE | May 25, 2001 | Substantially Equivalent |
| K970466 | RADIUS PTCA GUIDEWIRE | May 20, 1997 | Substantially Equivalent |