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510(k) K870825

NEW MODEL STYLES FOR AORTIC ARCH CANNULA by Shiley, Inc. — Product Code DQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1987
Date Received
March 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Catheter
Device Class
Class II
Regulation Number
870.1300
Review Panel
CV
Submission Type

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  • K903435 — SHILEY SPECIALIZED TRACHEOSTOMY TUBE (October 2, 1990)
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  • K901250 — PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR (June 11, 1990)
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  • K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (May 10, 1990)

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  • K894784 — MODIFIED SHILEY FEMORAL VENOUS CANNULA (March 28, 1990)
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