Cleared Traditional

K031997 - MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
(FDA 510(k) Clearance)

K031997 · Mallinckrodt Dar S.R.L. · Anesthesiology device

Nov 2003

Decision

151d

Days

Class 1

Risk

K031997 is an FDA 510(k) clearance for the MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM. This device is classified as a Catheters, Suction, Tracheobronchial (Class I - General Controls, product code BSY).

Submitted by Mallinckrodt Dar S.R.L. (Mirandola (Modena), IT). The FDA issued a Cleared decision on November 25, 2003, 151 days after receiving the submission on June 27, 2003.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6810.

Submission Details

510(k) Number	K031997 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 27, 2003
Decision Date	November 25, 2003
Days to Decision	151 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF