Cleared Traditional

SEEKER CROSSING SUPPORT CATHETER

K103367 · Bard Peripheral Vascular, Inc. · Cardiovascular
Dec 2010
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K103367 is an FDA 510(k) clearance for the SEEKER CROSSING SUPPORT CATHETER, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on December 8, 2010, 22 days after receiving the submission on November 16, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K103367 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2010
Decision Date December 08, 2010
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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