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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K011056
Device Name ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
Applicant
ARROW INTL., INC.
2400 BERNVILLE RD.
READING,  PA  19605
Applicant Contact THOMAS D NICKEL
Correspondent
ARROW INTL., INC.
2400 BERNVILLE RD.
READING,  PA  19605
Correspondent Contact THOMAS D NICKEL
Regulation Number870.5150
Classification Product Code
QEW  
Date Received04/06/2001
Decision Date 10/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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