SCIMED TRANSPORT CORONARY BALLOON DILATATION-INFUSION CATHETER
FDA premarket approval P860019/S113 · decided 1997-04-09
Approval details
- PMA number
- P860019
- Supplement
- S113
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SCIMED TRANSPORT CORONARY BALLOON DILATATION-INFUSION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Scimed Life Systems, Inc.
- Date received
- 1996-05-02
- Decision date
- 1997-04-09
- Days to decision
- 342 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR A NEW BALLOON DILATATION AND INFUSION CATHETER. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SCIMED(R) TRANSPORT(R) CORONARY BALLOON DILATATION-INFUSION CATHETER AND IS INDICATD FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FO RTHE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE TRANSPORT(R) CATHETER IS ALSO INTENDED TO INFUSION FLUIDS SUCH AS HEPARINIZED SALINE, AND THROMBOLYTIC AGENTS SUCH AS UROKINASE, INTOT EH VASCULATURE WHEN TH
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SCIMED INFORMER PRESSURE WIRE SYSTEM (K974241) | Scimed Life Systems, Inc. | 1998-11-12 |
| SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER (K981788) | Scimed Life Systems, Inc. | 1998-08-18 |
| SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES (K980360) | Scimed Life Systems, Inc. | 1998-04-29 |
| SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS (K974559) | Scimed Life Systems, Inc. | 1998-02-23 |
| SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER (K974684) | Scimed Life Systems, Inc. | 1998-02-19 |
| LUGE GUIDE WIRE (K973945) | Scimed Life Systems, Inc. | 1998-01-12 |
| SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER (K970823) | Scimed Life Systems, Inc. | 1997-06-03 |
| CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID (K964551) | Scimed Life Systems, Inc. | 1997-05-21 |