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FDA 510(k)

CATH-GUIDE

K-Number: K955645 · 1996-03-12

ApplicantHudson Respiratory Care, Inc.
Decision Date1996-03-12
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CATH-GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Respiratory Care, Inc.. It received FDA 510(k) clearance on 1996-03-12 under 510(k) number K955645. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATH-GUIDE?

CATH-GUIDE is a medical device that received FDA 510(k) clearance on 1996-03-12. The listed applicant is Hudson Respiratory Care, Inc.. The 510(k) number is K955645.

When did CATH-GUIDE receive FDA 510(k) clearance?

CATH-GUIDE received FDA 510(k) clearance on 1996-03-12, under 510(k) number K955645.

Who is the listed applicant for CATH-GUIDE?

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

What is the FDA product code for CATH-GUIDE?

The FDA product code for CATH-GUIDE is BSY.

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Other records listing Hudson Respiratory Care, Inc. 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.

K031383MODEL 780K011125NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCIK011134OXYGEN SUPPLY TUBING, MODEL 1115K010402SMOOTH-FLO CIRCUITK001213CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60K993355HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43

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Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., Inc.

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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