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FDA 510(k)

SHILEY DISPOS. DECANNULATION PLUG W/SW/

K-Number: K843730 · 1984-10-19

ApplicantShiley, Inc.
Decision Date1984-10-19
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SHILEY DISPOS. DECANNULATION PLUG W/SW/ is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1984-10-19 under 510(k) number K843730. 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 SHILEY DISPOS. DECANNULATION PLUG W/SW/?

SHILEY DISPOS. DECANNULATION PLUG W/SW/ is a medical device that received FDA 510(k) clearance on 1984-10-19. The listed applicant is Shiley, Inc.. The 510(k) number is K843730.

When did SHILEY DISPOS. DECANNULATION PLUG W/SW/ receive FDA 510(k) clearance?

SHILEY DISPOS. DECANNULATION PLUG W/SW/ received FDA 510(k) clearance on 1984-10-19, under 510(k) number K843730.

Who is the listed applicant for SHILEY DISPOS. DECANNULATION PLUG W/SW/?

The FDA 510(k) record lists Shiley, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHILEY DISPOS. DECANNULATION PLUG W/SW/?

The FDA product code for SHILEY DISPOS. DECANNULATION PLUG W/SW/ is BTO.

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Other records listing Shiley, Inc. as applicant

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K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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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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