ACS SWAP-IT GUIDE WIRE EXCHANGE DEVICE CATHETER
FDA premarket approval P810046/S186 · decided 1998-03-13
Approval details
- PMA number
- P810046
- Supplement
- S186
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS SWAP-IT GUIDE WIRE EXCHANGE DEVICE CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1998-01-23
- Decision date
- 1998-03-13
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for ACS Swap-It(TM) Guide Wire Exchange Device which is an accessory to Guidant ACS RX (Rail) catheters. This device will be marketed under the trade name ACS Swap-It(TM) Guide Wire Exchange Device and is indicated for use within a guiding catheter to facilitate the exchange of a 0.014 inch guide wire while maintaining the position of an ACS RX(R) (Rail) catheter.
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