FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
K Number: K103618
·
Decision Jan 5, 2011
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
35
Review Days
26
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Basic Information
- Device Name
- TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
- K Number
- K103618
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ev3, Inc.
- Date Received
- December 10, 2010
- Decision Date
- January 5, 2011
- Product Code
- MCW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | FDA class 2 | Cardiovascular |
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Other Clearances by Ev3, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K141118 | NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER | Jul 18, 2014 | Substantially Equivalent |
| K132777 | NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER | Sep 26, 2013 | Substantially Equivalent |
| K130911 | RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER | May 24, 2013 | Substantially Equivalent |
| K123544 | RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER | Feb 12, 2013 | Substantially Equivalent |
| K111723 | TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | Oct 27, 2011 | Substantially Equivalent |
| K111010 | SPIDERFX EMBOLIC PROTECTION DEVICE | Oct 27, 2011 | Substantially Equivalent |
| K111490 | MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS | Sep 16, 2011 | Substantially Equivalent |
| K110319 | EVERCROSS 0.035 OTW PTA DILATATION CATHETER | Apr 14, 2011 | Substantially Equivalent |
| K103322 | EVERCROSS 0.035 OTW PTA DILATION CATHETER | Dec 6, 2010 | Substantially Equivalent |
| K100063 | HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL | Feb 2, 2010 | Substantially Equivalent |