Atlas FDA

BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE

FDA 510(k) clearance K912469 · decided 1991-06-19

Clearance details

K-number
K912469
Device name
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
Applicant
Bivona Medical Technologies
Decision
Substantially Equivalent
Date received
1991-06-04
Decision date
1991-06-19
Days to decision
15 days
Clearance type
Traditional
Product code
BTO
Device class
2
Regulation number
868.5800
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Gary, IN, US
Third-party review
No
Expedited review
No

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RecordFirmDate
5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm (K242921)Vitaltec Corporation2025-06-10
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Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm (K192511)Venner Medical (Singapore) Pte, Ltd.2020-07-22
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube (K173384)Smiths Medical Ads, Inc.2018-04-10
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Recalls involving this device

RecordFirmDate
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT recall (Z-2588-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RA recall (Z-2589-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Prod recall (Z-2590-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Cod recall (Z-2591-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLE recall (Z-2592-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLU recall (Z-2593-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH recall (Z-2594-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNC recall (Z-2595-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLE recall (Z-2596-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TR recall (Z-2597-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STR recall (Z-2598-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STA recall (Z-2599-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PL recall (Z-2600-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD recall (Z-2601-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOM recall (Z-2602-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Prod recall (Z-2603-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIR recall (Z-2604-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY recall (Z-2605-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product recall (Z-2606-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT recall (Z-2607-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm recall (Z-2608-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm recall (Z-2609-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Produc recall (Z-2610-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm recall (Z-2611-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm recall (Z-2612-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm recall (Z-2613-2024)Smiths Medical ASD Inc.2024-08-23
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number recall (Z-2614-2024)Smiths Medical ASD Inc.2024-08-23
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEO recall (Z-2615-2024)Smiths Medical ASD Inc.2024-08-23
Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) recall (Z-0656-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange) recall (Z-0657-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 Product Usage: This tube is in recall (Z-0658-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 Product Usage: This tube is in recall (Z-0659-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped recall (Z-0660-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight recall (Z-0661-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With recall (Z-0662-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With recall (Z-0663-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (W recall (Z-0664-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (W recall (Z-0665-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona TTS Cuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange recall (Z-0666-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona TTS Cuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange recall (Z-0667-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange) recall (Z-0668-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange) recall (Z-0669-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange) recall (Z-0670-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) P recall (Z-0671-2012)Smiths Medical ASD, Inc.2012-01-19