FDA 510(k)

WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR

K-Number: K843785 · 1984-10-23

Decision Date1984-10-23

Product CodeBTO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical Devices , Ltd.. It received FDA 510(k) clearance on 1984-10-23 under 510(k) number K843785. 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 WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR?

WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR is a medical device that received FDA 510(k) clearance on 1984-10-23. The listed applicant is Intl. Medical Devices , Ltd.. The 510(k) number is K843785.

When did WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR receive FDA 510(k) clearance?

WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR received FDA 510(k) clearance on 1984-10-23, under 510(k) number K843785.

Who is the listed applicant for WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR?

The FDA 510(k) record lists Intl. Medical Devices , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR?

The FDA product code for WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR is BTO.

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Related Devices (Code: BTO)

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 Corporation K2429215300600-5301000 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 Corporation K233713Pilling Tracheostomy TubesTeleflex Medical K192511Venner 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.