NINJA FX PTCA DILATATION CATHETER
FDA premarket approval P880003/S080 · decided 2000-07-07
Approval details
- PMA number
- P880003
- Supplement
- S080
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NINJA FX PTCA DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Cordis Corp.
- Date received
- 1999-10-07
- Decision date
- 2000-07-07
- Days to decision
- 274 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR NINJA(FX) PTCA DILATATION CATHETER WITH THE FOLLOWING BALLOON SIZES: 1.5 MM X 20 MM, 25 MM, AND 30 MM; 2.0 MM X 20 MM, 25 MM, AND 30 MM; 2.25 MM - 4.0 MM (IN 1/4 MM SIZES) X 10 MM, 15 MM, 18MM, 20 MM, 25 MM, AND 30 MM; 4.5 MM X 20 MM; AND 5.0 MM X 20 MM. THE NINJA(FX) PTCA DILATATINO CATHETER IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
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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 |