Cleared Traditional

K954848 - HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
(FDA 510(k) Clearance)

K954848 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular

Feb 1996

Decision

101d

Days

Class 2

Risk

K954848 is an FDA 510(k) clearance for the HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT. This device is classified as a Graft, Vascular, Synthetic/biologic Composite (Class II — Special Controls, product code MAL).

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on February 1, 1996, 101 days after receiving the submission on October 23, 1995.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number	K954848 FDA.gov
FDA Decision	Cleared ST
Date Received	October 23, 1995
Decision Date	February 01, 1996
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—