ClearanceBrief
510(k) K962173 ยท JOH Tube Tracheostomy And Tube Cuff

SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES

ApplicantMallinckrodt Medical, St Louis MO, US
DecisionSubstantially Equivalent, Oct 4, 1996
ReceivedJun 5, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K962173

DateFirm and productCodeLinked 510(k)
Aug 10, 2012Nellcor Puritan Bennett Inc. (dba Covidien LP)
Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper a
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 6 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper a
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 8 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper a
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 10 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway o
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway o
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway o
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for byp
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 FEN-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for b
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 FEN-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for b
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube, 4 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube, 6 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube, 8 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube, 10 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 4 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upp
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upp
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upp
Terminated
JOHNone listed
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 10 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of up
Terminated
JOHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.