INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)

Introducer, Catheter

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Input 10f/11/f Introducer Set(010101(10f), 011101(11f).

Pre-market Notification Details

Device IDK961135
510k NumberK961135
Device Name:INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)
ClassificationIntroducer, Catheter
Applicant C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica,  MA  01821
ContactRobert T Miragliuolo
CorrespondentRobert T Miragliuolo
C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica,  MA  01821
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-21
Decision Date1996-04-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169014439 K961135 000
20643169014422 K961135 000

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