QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS
FDA premarket approval P860019/S182 · decided 2002-10-01
Approval details
- PMA number
- P860019
- Supplement
- S182
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Scimed Life Systems, Inc.
- Date received
- 2002-04-16
- Decision date
- 2002-10-01
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE QUANTUM MAVERICK MONORAIL AND OTW PTCA CATHETERS AND APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY, COSMED OF RI, COVENTRY, RHODE ISLAND. THE QUANTUM MAVERICK MONORAIL & OTW PTCA CATHETERS ARE AVAILABLE IN LENGTHS OF 8, 12, 15, 20 AND 30 MM, WITH DIAMETERS RANGING FROM 2.00 TO 4.00 MM IN 1/4MM INCREMENTS AND 4.5 TO 5.0 MM IN 1/2 MM INCREMENTS (EXCEPT FOR THE 20 MM LENGTH). THE DEVICES, AS MODIFIED, ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY AR
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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 |