MEADOX EXXCEL EPTFE VASCULAR GRAFT

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Meadox Exxcel Eptfe Vascular Graft.

Pre-market Notification Details

Device IDK962433
510k NumberK962433
Device Name:MEADOX EXXCEL EPTFE VASCULAR GRAFT
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 15 THORNTON RD. Oakland,  NJ  07436
ContactStephen B Anderson
CorrespondentStephen B Anderson
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 15 THORNTON RD. Oakland,  NJ  07436
Product CodeDSY  
CFR Regulation Number870.3450 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-24
Decision Date1997-03-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00384409001913 K962433 000
00384409001760 K962433 000
00384409001753 K962433 000
00384409001746 K962433 000
00384409001739 K962433 000
00384409001722 K962433 000
00384409001715 K962433 000
00384409001708 K962433 000
00384409001692 K962433 000
00384409001685 K962433 000
00384409001678 K962433 000
00384409001661 K962433 000
00384409001777 K962433 000
00384409001784 K962433 000
00384409001791 K962433 000
00384409001906 K962433 000
00384409001890 K962433 000
00384409001883 K962433 000
00384409001876 K962433 000
00384409001869 K962433 000
00384409001852 K962433 000
00384409001845 K962433 000
00384409001838 K962433 000
00384409001821 K962433 000
00384409001814 K962433 000
00384409001807 K962433 000
00384409001654 K962433 000
00384409001647 K962433 000
00384409001494 K962433 000
00384409001487 K962433 000
00384409001470 K962433 000
00384409001463 K962433 000
00384409001456 K962433 000
00384409001449 K962433 000
00384409001432 K962433 000
00384409001425 K962433 000
00384409001418 K962433 000
00384409001401 K962433 000
00384409001395 K962433 000
00384409001500 K962433 000
00384409001517 K962433 000
00384409001524 K962433 000
00384409001630 K962433 000
00384409001623 K962433 000
00384409001616 K962433 000
00384409001609 K962433 000
00384409001593 K962433 000
00384409001586 K962433 000
00384409001579 K962433 000
00384409001562 K962433 000
00384409001555 K962433 000
00384409001548 K962433 000
00384409001531 K962433 000
00384409000299 K962433 000
00384409001920 K962433 000
00384409002460 K962433 000
00384409002316 K962433 000
00384409002309 K962433 000
00384409002293 K962433 000
00384409002286 K962433 000
00384409002279 K962433 000
00384409002262 K962433 000
00384409002255 K962433 000
00384409002248 K962433 000
00384409002231 K962433 000
00384409002224 K962433 000
00384409002217 K962433 000
00384409002323 K962433 000
00384409002330 K962433 000
00384409002347 K962433 000
00384409002453 K962433 000
00384409002446 K962433 000
00384409002439 K962433 000
00384409002422 K962433 000
00384409002415 K962433 000
00384409002408 K962433 000
00384409002392 K962433 000
00384409002385 K962433 000
00384409002378 K962433 000
00384409002361 K962433 000
00384409002354 K962433 000
00384409002200 K962433 000
00384409002194 K962433 000
00384409002040 K962433 000
00384409002033 K962433 000
00384409002026 K962433 000
00384409002019 K962433 000
00384409002002 K962433 000
00384409001999 K962433 000
00384409001982 K962433 000
00384409001975 K962433 000
00384409001968 K962433 000
00384409001951 K962433 000
00384409001944 K962433 000
00384409002057 K962433 000
00384409002064 K962433 000
00384409002071 K962433 000
00384409002187 K962433 000
00384409002170 K962433 000
00384409002163 K962433 000
00384409002156 K962433 000
00384409002149 K962433 000
00384409002132 K962433 000
00384409002125 K962433 000
00384409002118 K962433 000
00384409002101 K962433 000
00384409002095 K962433 000
00384409002088 K962433 000
00384409001937 K962433 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.