510(k) K912469 ยท BTO Tube, Tracheostomy (W/Wo Connector)
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Jun 19, 1991 |
| Received | Jun 4, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912469
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170;
b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CU Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160;
b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/Li Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025 Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030;
b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035;
c) N Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25;
b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25 Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30;
b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025;
b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40;
b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Pro Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60 Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40;
b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25;
b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Product Code/List Number/Item Code 60PFSS25 Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30;
b) 3.5MM FLEXTEND PEDIATRIC STANDARD S Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025;
b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product C Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025;
b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 6 Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025;
b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025;
3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Cod Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025;
b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N0 Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040 Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25;
b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25;
b) NEONATAL TRACHEOSTOMY TUBE Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025;
b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P03 Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40;
b) PEDIATRIC TRACHEOSTOMY TUBE 4 Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40;
b) PEDIATRIC TRACHEOSTOMY Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25;
b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25;
b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Numb Open, Classified |
BTO | None listed |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025;
b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , P Open, Classified |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange)
Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange). Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5
Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocesse Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5
Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocesse Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange)
Product Usage: This tube is intended to provide direct airway access for a tracheostomized p Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange)
Product Usage: This tube is intended to provide direct airway access for a tracheostomized pa Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange)
Product Usage: This tube is intended to provide direct airway access for a tracheost Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange)
Product Usage: This tube is intended to provide direct airway access for a tracheos Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (With a V-Shaped Neck Flange)
Product Usage: This tube is intended to provide direct airway access for a trac Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (With a Straight Neck Flange)
Product Usage: This tube is intended to provide direct airway access for a trach Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona TTS Cuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange)
Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona TTS Cuffed Pediatric Tracheostomy Tube
Sizes 2.5 - 5.5 (With a Straight Neck Flange)
Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange)
Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up t Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange)
Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange) Terminated |
BTO | None listed |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona Uncuffed Neonatal Tracheostomy Tube
Sizes 2.5 - 4.0 (With a Straight Neck Flange)
Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up t Terminated |
BTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.