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FDA 510(k)

TRIGUARD(TM) SUCTION SYSTEM

K-Number: K945950 · 1994-12-27

ApplicantVital Signs, Inc.
Decision Date1994-12-27
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRIGUARD(TM) SUCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 1994-12-27 under 510(k) number K945950. 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 TRIGUARD(TM) SUCTION SYSTEM?

TRIGUARD(TM) SUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 1994-12-27. The listed applicant is Vital Signs, Inc.. The 510(k) number is K945950.

When did TRIGUARD(TM) SUCTION SYSTEM receive FDA 510(k) clearance?

TRIGUARD(TM) SUCTION SYSTEM received FDA 510(k) clearance on 1994-12-27, under 510(k) number K945950.

Who is the listed applicant for TRIGUARD(TM) SUCTION SYSTEM?

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

What is the FDA product code for TRIGUARD(TM) SUCTION SYSTEM?

The FDA product code for TRIGUARD(TM) SUCTION SYSTEM is BSY.

Related Clinical Trials

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Other records listing Vital Signs, 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.

K112902ENFLOW IV FLUID WARMERK041309IMASK TMK030985BREAS PV 10I CPAP SYSTEM, MODEL PV 10IK022402DISPOSABLE PRESSURE MANOMETERK021315SURE-LOKK002454BREAS HA50 HUMIDIFIER, MODEL HA50

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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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