Cleared Special

K011217 - CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT (FDA 510(k) Clearance)

K011217 · Abbott Laboratories · Cardiovascular device
May 2001
Decision
26d
Days
Class 2
Risk

K011217 is an FDA 510(k) clearance for the CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 16, 2001, 26 days after receiving the submission on April 20, 2001.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K011217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2001
Decision Date May 16, 2001
Days to Decision 26 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DQO — Catheter, Intravascular, Diagnostic
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.1200