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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.
 
Trade NameACS SWAP-IT GUIDE WIRE EXCHANGE DEVICE CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary dilatation catheter
Regulation Number870.5100
ApplicantGUIDANT CORP.
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 - other
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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