FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
K Number: K100063
·
Decision Feb 2, 2010
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
89
Applicant Total
35
Review Days
22
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Basic Information
- Device Name
- HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
- K Number
- K100063
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ev3, Inc.
- Date Received
- January 11, 2010
- Decision Date
- February 2, 2010
- Product Code
- MJN
- 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 |
|---|---|---|---|
| MJN | Catheter, Intravascular Occluding, Temporary | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K130911 | RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER | May 24, 2013 | Substantially Equivalent |
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| 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 |
| K103618 | TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM | Jan 5, 2011 | Substantially Equivalent |
| K103322 | EVERCROSS 0.035 OTW PTA DILATION CATHETER | Dec 6, 2010 | Substantially Equivalent |