FDA 510(k) Application Details - K994155

Device Classification Name Catheter, Continuous Flush

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510(K) Number K994155
Device Name Catheter, Continuous Flush
Applicant BOSTON SCIENTIFIC, TARGET
47900 BAYSIDE PKWY.
FREMONT, CA 94538 US
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Contact ROXANNE K BAXTER
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 12/09/1999
Decision Date 08/03/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K994155


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