Cleared Special

MODIFICATION TO T-REX BIOPSY FORCEPS

K000409 · Boston Scientific Corp · Cardiovascular
Feb 2000
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K000409 is an FDA 510(k) clearance for the MODIFICATION TO T-REX BIOPSY FORCEPS, a Device, Biopsy, Endomyocardial (Class II — Special Controls, product code DWZ), submitted by Boston Scientific Corp (Redmond, US). The FDA issued a Cleared decision on February 28, 2000, 20 days after receiving the submission on February 8, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4075.

Submission Details

510(k) Number K000409 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2000
Decision Date February 28, 2000
Days to Decision 20 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWZ — Device, Biopsy, Endomyocardial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4075

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