TidalPort-AP Implantable Apheresis Vascular Access Port

Subcutaneous Implanted Apheresis Port

Norfolk Medical Products, Inc.

The following data is part of a premarket notification filed by Norfolk Medical Products, Inc. with the FDA for Tidalport-ap Implantable Apheresis Vascular Access Port.

Pre-market Notification Details

Device IDK192291
510k NumberK192291
Device Name:TidalPort-AP Implantable Apheresis Vascular Access Port
ClassificationSubcutaneous Implanted Apheresis Port
Applicant Norfolk Medical Products, Inc. 7350 N. Ridgeway Avenue Skokie,  IL  60076
ContactNatan Pheil
CorrespondentNatan Pheil
Norfolk Medical Products, Inc. 7350 N. Ridgeway Avenue Skokie,  IL  60076
Product CodePTD  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-23
Decision Date2020-08-20

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