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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceACS SWAP-IT GUIDE WIRE EXCHANGE DEVICE CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 ynez rd.
temecula, CA 92591
PMA NumberP810046
Supplement NumberS186
Date Received01/23/1998
Decision Date03/13/1998
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order 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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