SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
FDA premarket approval P860019/S143 · decided 1998-09-16
Approval details
- PMA number
- P860019
- Supplement
- S143
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Scimed Life Systems, Inc.
- Date received
- 1998-04-14
- Decision date
- 1998-09-16
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for new PTCA catheter models. The devices, as modified, will be marketed under the trade names SCIMED(R) VIVA(TM) PTCA Catheters and SCIMED(R) LONG VIVA(TM) PTCA Catheters and are 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 |
|---|---|---|
| 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 |