Cleared Traditional

SPARROWHAWK DISPOSABLE

K010473 · Atc Technologies, Inc. · Cardiovascular
Jun 2001
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K010473 is an FDA 510(k) clearance for the SPARROWHAWK DISPOSABLE, a Device, Biopsy, Endomyocardial (Class II — Special Controls, product code DWZ), submitted by Atc Technologies, Inc. (Woburn, US). The FDA issued a Cleared decision on June 6, 2001, 106 days after receiving the submission on February 20, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4075.

Submission Details

510(k) Number K010473 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2001
Decision Date June 06, 2001
Days to Decision 106 days
Submission Type Traditional
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