MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM

Catheters, Suction, Tracheobronchial

MALLINCKRODT DAR S.R.L.

The following data is part of a premarket notification filed by Mallinckrodt Dar S.r.l. with the FDA for Mallinckrodt Dar Ty-care / Ty-care Exel Closed Suction System.

Pre-market Notification Details

• Device ID: K031997
• 510k Number: K031997
• Device Name: MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
• Classification: Catheters, Suction, Tracheobronchial
• Applicant: MALLINCKRODT DAR S.R.L. VIA G.BOVE, 2/4/6/8 Mirandola (modena), IT 41037
• Contact: Giuseppe Tomasini
• Correspondent: Giuseppe Tomasini; MALLINCKRODT DAR S.R.L. VIA G.BOVE, 2/4/6/8 Mirandola (modena), IT 41037
• Product Code: BSY
• CFR Regulation Number: 868.6810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-06-27
• Decision Date: 2003-11-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20884522033296	K031997	000
20884521810935	K031997	000
20884521810928	K031997	000
20884521810911	K031997	000
20884521810904	K031997	000
20884521810898	K031997	000
20884521810881	K031997	000
20884521810836	K031997	000
20884521810829	K031997	000
20884521810812	K031997	000
20884521810805	K031997	000
20884521810942	K031997	000
20884521810997	K031997	000
20884522032824	K031997	000
20884522032817	K031997	000
20884522032800	K031997	000
20884522032794	K031997	000
20884522032787	K031997	000
20884521811079	K031997	000
20884521811031	K031997	000
20884521811024	K031997	000
20884521811017	K031997	000
20884521811000	K031997	000
20884521810799	K031997	000
20884521810782	K031997	000
20884521810775	K031997	000
20884521810515	K031997	000
20884521810508	K031997	000
20884521810492	K031997	000
20884521810485	K031997	000
20884521810478	K031997	000
20884521810461	K031997	000
20884521810454	K031997	000
20884521810447	K031997	000
20884521810430	K031997	000
20884521101750	K031997	000
20884521810522	K031997	000
20884521810539	K031997	000
20884521810768	K031997	000
20884521810652	K031997	000
20884521810621	K031997	000
20884521810614	K031997	000
20884521810607	K031997	000
20884521810591	K031997	000
20884521810577	K031997	000
20884521810560	K031997	000
20884521810553	K031997	000
20884521810546	K031997	000
20884521066882	K031997	000
20884522033302	K031997	000
10884521081895	K031997	000
10884521066922	K031997	000
20884521811093	K031997	000
20884521811086	K031997	000
20884521810874	K031997	000
20884521810867	K031997	000
20884521810850	K031997	000
20884521810843	K031997	000
10884522040365	K031997	000
10884522040358	K031997	000
10884522040341	K031997	000
10884521066939	K031997	000
10884521066946	K031997	000
10884521081888	K031997	000
10884521081772	K031997	000
10884521081765	K031997	000
10884521081758	K031997	000
10884521081741	K031997	000
10884521081734	K031997	000
10884521081710	K031997	000
10884521081703	K031997	000
10884521081697	K031997	000
10884521081680	K031997	000
10884522040334	K031997	000
10884522039390	K031997	000
10884522039383	K031997	000
10884522030717	K031997	000
10884522030700	K031997	000
10884521082243	K031997	000
10884521082236	K031997	000
10884521082151	K031997	000
10884521082144	K031997	000
10884521082137	K031997	000
10884521081819	K031997	000
10884521081802	K031997	000
10884521081796	K031997	000
10884522030724	K031997	000
10884522034210	K031997	000
10884522037631	K031997	000
10884522037624	K031997	000
10884522037617	K031997	000
10884522035217	K031997	000
10884522035200	K031997	000
10884522035194	K031997	000
10884522035187	K031997	000
10884522034241	K031997	000
10884522034234	K031997	000
10884522034227	K031997	000
10884521081789	K031997	000