Cleared Traditional

PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT

K040415 · Synovis Surgical Innovations · Cardiovascular

Apr 2004

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K040415 is an FDA 510(k) clearance for the PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT, a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Synovis Surgical Innovations (St. Paul, US). The FDA issued a Cleared decision on April 14, 2004, 56 days after receiving the submission on February 18, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number	K040415 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 2004
Decision Date	April 14, 2004
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF