TITAN AND TITAN XL PTCA DILATATION CATHETERS
FDA premarket approval P880003/S052 · decided 1996-03-13
Approval details
- PMA number
- P880003
- Supplement
- S052
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TITAN AND TITAN XL PTCA DILATATION CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Cordis Corp.
- Date received
- 1995-11-22
- Decision date
- 1996-03-13
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR: 1)TITAN AND TITAN XL PTCA DILATATION CATHETERS WITH 3.25MM AND 3.75MM DIAMETER BALLOONS AVAILABLE IN 9MM OR 18MM LENGTHS 2)A MODIFIED HUB BONDING PROCESS 3)A CHANGE IN THE DEVICE NAME FROM TITAN 18 PTCA DILATATION CATHEGTERS TO TITAN PTCA DILATATION CATHETERS 4)ONE SET OF INSTRUCTION FOR USE FOR ALL TITAN AND TITAN XL PTCA DILATATION CATHETERS
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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 |