BRONCHO-CATH

Tube, Bronchial (w/wo Connector)

MALLINCKRODT CRITICAL CARE

The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Broncho-cath.

Pre-market Notification Details

• Device ID: K771219
• 510k Number: K771219
• Device Name: BRONCHO-CATH
• Classification: Tube, Bronchial (w/wo Connector)
• Applicant: MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: BTS
• CFR Regulation Number: 868.5720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1977-07-05
• Decision Date: 1977-08-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521831667	K771219	000
10884521831797	K771219	000
10884521831803	K771219	000
10884521831568	K771219	000
10884522008785	K771219	000
10884522008792	K771219	000
10884522008808	K771219	000
10884522028936	K771219	000
10884522028950	K771219	000
10884521831773	K771219	000
10884521831582	K771219	000
10884521831575	K771219	000
20884521831787	K771219	000
20884521831671	K771219	000
20884521831688	K771219	000
20884521831657	K771219	000
20884521831664	K771219	000
20884521831534	K771219	000
10884521831544	K771219	000
10884521831551	K771219	000
10884522028967	K771219	000
10884522028974	K771219	000
20884522008775	K771219	000
30884522028954	K771219	000
30884522028961	K771219	000
30884522028978	K771219	000
40884522008717	K771219	000
40884522008724	K771219	000
40884522008731	K771219	000
40884522008748	K771219	000
40884522008755	K771219	000
30884522008802	K771219	000
30884522008796	K771219	000
30884522008789	K771219	000
20884522028933	K771219	000
30884522008710	K771219	000
30884522008727	K771219	000
30884522008734	K771219	000
30884522008741	K771219	000
30884522008758	K771219	000
30884522008765	K771219	000
30884522008772	K771219	000
40884522008762	K771219	000