FDA 510(k)

MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES

K-Number: K880247 · 1988-02-12

Decision Date1988-02-12

Product CodeBTO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1988-02-12 under 510(k) number K880247. 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 MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES?

MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES is a medical device that received FDA 510(k) clearance on 1988-02-12. The listed applicant is Shiley, Inc.. The 510(k) number is K880247.

When did MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES receive FDA 510(k) clearance?

MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES received FDA 510(k) clearance on 1988-02-12, under 510(k) number K880247.

Who is the listed applicant for MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES?

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 MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES?

The FDA product code for MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES is BTO.

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Other records listing Shiley, Inc. as applicant

K920594SHILEY PERFUSION TUBING SETS K910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM K911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 K910923BCD ADVANCED K901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS K903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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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.