MAVERICK XL PTCA CATHETER (MONORAIL)
FDA premarket approval P860019/S183 · decided 2002-10-24
Approval details
- PMA number
- P860019
- Supplement
- S183
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAVERICK XL PTCA CATHETER (MONORAIL)
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Scimed Life Systems, Inc.
- Date received
- 2002-05-02
- Decision date
- 2002-10-24
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR MAVERICK XL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PTCA) CATHETERS (MONORAIL) AND APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY, COSMED OF RI, COVENTRY, RHODE ISLAND. THE MAVERICK XL PTCA CATHETERS ARE AVAILABLE IN LENGTHS OF 15 AND 20 MM, WITH DIAMETERS OF 4.0, 4.5, 5.0, 5.5 AND 6.0 MM. THE DEVICES, AS MODIFIED, ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION AND FOR THE
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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 |