REDO CENTRAL VENOUS CATHETER-NEONATE

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

INTL. HOSPITAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Intl. Hospital Products, Inc. with the FDA for Redo Central Venous Catheter-neonate.

Pre-market Notification Details

Device IDK841443
510k NumberK841443
Device Name:REDO CENTRAL VENOUS CATHETER-NEONATE
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant INTL. HOSPITAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-06
Decision Date1984-07-27

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