FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
K Number: K040653
·
Decision Apr 28, 2004
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
35
Review Days
47
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Basic Information
- Device Name
- PARAMOUNT MINI GPS BILIARY STENT SYSTEM
- K Number
- K040653
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Ev3, Inc.
- Date Received
- March 12, 2004
- Decision Date
- April 28, 2004
- Product Code
- FGE
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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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 |
| K103618 | TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM | Jan 5, 2011 | Substantially Equivalent |
| K103322 | EVERCROSS 0.035 OTW PTA DILATION CATHETER | Dec 6, 2010 | Substantially Equivalent |