FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO GUIDE CATHETER XP
K Number: K082143
·
Decision Aug 25, 2008
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
54
Applicant Total
315
Review Days
26
Basic Information
- Device Name
- MICRO GUIDE CATHETER XP
- K Number
- K082143
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CORDIS CORP.
- Date Received
- July 30, 2008
- Decision Date
- August 25, 2008
- Product Code
- PDU
- 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 |
|---|---|---|---|
| PDU | Catheter For Crossing Total Occlusions | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PDU), ordered by most recent decision date.
LimFlow ARC
FDA 510(k)
FDA Class 2
·Cardiovascular
PowerWire Radiofrequency Guidewire Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
SoundBite® Crossing System XS Peripheral
FDA 510(k)
FDA Class 2
·Cardiovascular
Tigereye ST CTO-Crossing Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Tunnel Crossing Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
LimFlow ARC
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by CORDIS CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K130981 | FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM | Mar 12, 2014 | Unknown |
| K112797 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER | May 4, 2012 | Substantially Equivalent |
| K101651 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE | Jul 9, 2010 | Substantially Equivalent |
| K062798 | SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB | Feb 6, 2008 | Unknown |
| K060877 | PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX | Apr 27, 2006 | Unknown |
| K050645 | CORDIS AMIIA .014 PTA BALLOON CATHETER | Apr 1, 2005 | Substantially Equivalent |
| K040592 | CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE | Dec 17, 2004 | Substantially Equivalent |
| K042969 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Nov 8, 2004 | Unknown |
| K033394 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM | Dec 22, 2003 | Unknown |
| K032137 | PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Sep 17, 2003 | Unknown |