FDA 510(k)

CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT

K-Number: K990949 · 1999-06-15

Decision Date1999-06-15

Product CodeCAH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT is the device name listed in this FDA 510(k) record. The listed applicant is Intersurgical, Inc.. It received FDA 510(k) clearance on 1999-06-15 under 510(k) number K990949. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT?

CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT is a medical device that received FDA 510(k) clearance on 1999-06-15. The listed applicant is Intersurgical, Inc.. The 510(k) number is K990949.

When did CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT receive FDA 510(k) clearance?

CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT received FDA 510(k) clearance on 1999-06-15, under 510(k) number K990949.

Who is the listed applicant for CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT?

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

What is the FDA product code for CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT?

The FDA product code for CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT is CAH.

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Other records listing Intersurgical, Inc. as applicant

K122077MANOMETER K122075DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER K121026FLO-GUARD BREATHING FILTER K092451INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER K092129INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 K092409HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER

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Related Devices (Code: CAH)

K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® Exhalation FilterAmbu A/S K241339Besmed Bacterial Filter and HMEFBesmed Health Business Corp K222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)Intersurgical , Ltd.

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.