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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K211078
Device Name Progreat Lambda
Applicant
Terumo Clinical Supply Co., Ltd.
3, Kawashima-Takehayamachi
Kakamigahara,  JP 501-6024
Applicant Contact Vaibhav Sivaramakrishan
Correspondent
Terumo Medical Corporation
265 Davidson Ave., Suite 320
Somerset,  NJ  08873
Correspondent Contact Vaibhav Sivaramakrishan
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
KRA  
Date Received04/12/2021
Decision Date 12/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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