FDA 510(k) Premarket Notification K962639: IMPRA CARBOFLO EPTFE VASCULAR GRAFT

Submission Details & Decision

Normalized public record details for 510(k) notification K962639.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K962639

Applicant / Sponsor

Impra, Inc.

Device Name

IMPRA CARBOFLO EPTFE VASCULAR GRAFT

Product Code

DSY

Decision Date

1996-10-03

Decision / Status

Unknown (SESP)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

1996-07-05

Related Establishments / Registrations

C.R. BARD, INC. Registration: 1018233 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
LEMAITRE VASCULAR, INC. Registration: 1220948 View Registration
Intervascular SAS Registration: 1640201 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
MERIT MEDICAL SYSTEMS, INC. Registration: 1721504 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
GENESEE BIOMEDICAL, INC. Registration: 1723241 View Registration
Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration
W. L. GORE & ASSOCIATES, INC Registration: 2017233 View Registration
BARD PERIPHERAL VASCULAR, INC. Registration: 2020394 View Registration
Maquet Cardiovascular LLC Registration: 2242352 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
C.R. BARD, INC. Registration: 3006082230 View Registration
Merit Medical Nederland BV Registration: 3006950086 View Registration
Vascular Flow Technologies Ltd Registration: 3007676031 View Registration
Millstone Medical Outsourcing LLC Registration: 3010097171 View Registration
Synergy Health Marseille SAS Registration: 3010162973 View Registration
Sterigenics Italy SpA Registration: 3010407203 View Registration
Atrium Medical Corporation Registration: 3011175548 View Registration
Merit Medical Canada Ltd. Registration: 3012536737 View Registration
PECA LABS, INC. Registration: 3013718163 View Registration
Merit Medical Asia Company Limited Registration: 3015225571 View Registration
Merit Medical UK Limited Registration: 3015309643 View Registration
Merit Medical Australia Pty Ltd. Registration: 3033589330 View Registration
VASCUTEK LTD. Registration: 9612515 View Registration

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