DURA STAR RX PTCA BALLOON DILATATION CATHETER
FDA premarket approval P880003/S089 · decided 2007-08-29
Approval details
- PMA number
- P880003
- Supplement
- S089
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DURA STAR RX PTCA BALLOON DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Cordis Corp.
- Date received
- 2006-12-21
- Decision date
- 2007-08-29
- Days to decision
- 251 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A NEW CATHETER MODEL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DURA STAR RX PTCA BALLOON DILATATION CATHETER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. IN ADDITION, THE DURA STAR RX PTCA DILATATION CATHETER IS INDICATED FOR POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM (K130981) | Cordis Corp. | 2014-03-12 |
| POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (K112797) | Cordis Corp. | 2012-05-04 |
| ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE (K101651) | Cordis Corp. | 2010-07-09 |
| MICRO GUIDE CATHETER XP (K082143) | Cordis Corp. | 2008-08-25 |
| SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB (K062798) | Cordis Corp. | 2008-02-06 |
| PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX (K060877) | Cordis Corp. | 2006-04-27 |
| CORDIS AMIIA .014 PTA BALLOON CATHETER (K050645) | Cordis Corp. | 2005-04-01 |
| CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE (K040592) | Cordis Corp. | 2004-12-17 |