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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Balloon, Intra-Aortic And Control
510(k) Number K960713
Device Name 8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH)
Applicant
Arrow Intl., Inc.
3000 Bernville Rd.
Reading,  PA  19605
Applicant Contact THOMAS D NICKEL
Correspondent
Arrow Intl., Inc.
3000 Bernville Rd.
Reading,  PA  19605
Correspondent Contact THOMAS D NICKEL
Regulation Number870.3535
Classification Product Code
DSP  
Date Received02/21/1996
Decision Date 05/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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