FDA 510(k)

SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT

K-Number: K874450 · 1988-02-29

ApplicantSurgitech C/O Collier, Shannon, Rill & Scott

Decision Date1988-02-29

Product CodeBTO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Surgitech C/O Collier, Shannon, Rill & Scott. It received FDA 510(k) clearance on 1988-02-29 under 510(k) number K874450. 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 SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT?

SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT is a medical device that received FDA 510(k) clearance on 1988-02-29. The listed applicant is Surgitech C/O Collier, Shannon, Rill & Scott. The 510(k) number is K874450.

When did SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT receive FDA 510(k) clearance?

SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT received FDA 510(k) clearance on 1988-02-29, under 510(k) number K874450.

Who is the listed applicant for SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT?

The FDA 510(k) record lists Surgitech C/O Collier, Shannon, Rill & Scott as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT?

The FDA product code for SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT is BTO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Surgitech C/O Collier, Shannon, Rill & Scott as applicant

K911817ENDOSCOPIC CLIP APPLIER

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.