Cleared Traditional

K014109 - IN-TIME RETRIEVAL DEVICE (FDA 510(k) Clearance)

K014109 · Boston Scientific, Target · Cardiovascular device

Mar 2002

Decision

88d

Days

Class 2

Risk

K014109 is an FDA 510(k) clearance for the IN-TIME RETRIEVAL DEVICE. This device is classified as a Device, Percutaneous Retrieval (Class II - Special Controls, product code MMX).

Submitted by Boston Scientific, Target (Fremont, US). The FDA issued a Cleared decision on March 12, 2002, 88 days after receiving the submission on December 14, 2001.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K014109 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 14, 2001
Decision Date	March 12, 2002
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF