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FDA 510(k)

ARGYLE SILICONE TRACHESTOMY TUBE W/LOW

K-Number: K831720 · 1983-07-07

ApplicantSherwood Medical Co.
Decision Date1983-07-07
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ARGYLE SILICONE TRACHESTOMY TUBE W/LOW is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1983-07-07 under 510(k) number K831720. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARGYLE SILICONE TRACHESTOMY TUBE W/LOW?

ARGYLE SILICONE TRACHESTOMY TUBE W/LOW is a medical device that received FDA 510(k) clearance on 1983-07-07. The listed applicant is Sherwood Medical Co.. The 510(k) number is K831720.

When did ARGYLE SILICONE TRACHESTOMY TUBE W/LOW receive FDA 510(k) clearance?

ARGYLE SILICONE TRACHESTOMY TUBE W/LOW received FDA 510(k) clearance on 1983-07-07, under 510(k) number K831720.

Who is the listed applicant for ARGYLE SILICONE TRACHESTOMY TUBE W/LOW?

The FDA 510(k) record lists Sherwood Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARGYLE SILICONE TRACHESTOMY TUBE W/LOW?

The FDA product code for ARGYLE SILICONE TRACHESTOMY TUBE W/LOW is BTO.

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Other records listing Sherwood Medical Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSK960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAK962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEMK960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMK960677KANGAROO JEJUNAL FEEDING SYSTEMK960632KANGAROO FEEDING TUBE PLACMENT STYLET

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Related Devices (Code: BTO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)Vitaltec CorporationK2429215300600-5301000 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 6.0-10.0mmVitaltec CorporationK233713Pilling Tracheostomy TubesTeleflex MedicalK192511Venner 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 mmVenner Medical (Singapore) Pte, Ltd.K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tubeSmiths Medical Ads, Inc.K120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)Primed Halberstadt Medizintechnik GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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