SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.

Catheter, Embolectomy

CATHLAB CORP.

The following data is part of a premarket notification filed by Cathlab Corp. with the FDA for Silicone Bi-lumen Irrigation Embolectomy Cath..

Pre-market Notification Details

Device IDK893680
510k NumberK893680
Device Name:SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.
ClassificationCatheter, Embolectomy
Applicant CATHLAB CORP. 2695 DOW AVE. Tustin,  CA  92680
ContactDaniel R Lucas
CorrespondentDaniel R Lucas
CATHLAB CORP. 2695 DOW AVE. Tustin,  CA  92680
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-16
Decision Date1989-08-01

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