CAOClass IILife-sustaining
Airway, Esophageal (obturator)
Anesthesiology · 21 CFR 868.5650
MDR events14All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances6All time
Recent MDR events
14 adverse event reports on file
- MALLINCKRODTJun 21, 2021Injury8020889-2021-00059
- BIVONA CUSTOMIZED TRACHEOSTOMY TUBEJun 29, 2020Malfunction3012307300-2020-06371
- MALLINCKRODTNov 12, 2019Malfunction2936999-2019-00934
- MALLINCKRODTNov 12, 2019Malfunction2936999-2019-00935
- MALLINCKRODTMay 10, 2018InjuryMmj Sa De Cv(usd)2936999-2018-00334
- MALLINCKRODTMay 10, 2018Malfunction2936999-2018-00336
- MALLINCKRODTMay 2, 2017MalfunctionMmj Sa De Cv (usd)2936999-2017-05170
- MALLINCKRODTSep 2, 2015MalfunctionCovidien2936999-2015-00773
- MALLINCRODTSep 24, 2014MalfunctionCovidien2936999-2014-00849
- COMBITUBE 37 FR ROLLUPJan 8, 2013InjuryCovidien/ Formerly Tyco1317749-2013-00022
Event type breakdown
Malfunction10
Injury4
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Green Field Medical Sourcing, Inc.Feb 27, 1998
K971348 · FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
- Sharn, Inc.Aug 31, 1989
K894032 · EVAC-TUBE
- Sheridan Catheter Corp.Jan 19, 1988
K875226 · ESOPHAGEAL OBTURATOR/TRACHEAL TUBE
- Cranco Co.Mar 17, 1987
K864200 · VETA/VENTED ESOPHAGEAL TUBE AIRWAY
- Respironics, Inc.Nov 4, 1986
K863172 · RESPIRONICS PTL REVIVEEASY
- Mckesson Corp.Dec 9, 1976
K761195 · ESOPHAGEAL OBTURATION AIRWAY