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FDA 510(k)

ADI CATHETER WITH VALVE

K-Number: K952924 · 1995-08-18

ApplicantAsia Dynamics, Inc.
Decision Date1995-08-18
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ADI CATHETER WITH VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Asia Dynamics, Inc.. It received FDA 510(k) clearance on 1995-08-18 under 510(k) number K952924. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADI CATHETER WITH VALVE?

ADI CATHETER WITH VALVE is a medical device that received FDA 510(k) clearance on 1995-08-18. The listed applicant is Asia Dynamics, Inc.. The 510(k) number is K952924.

When did ADI CATHETER WITH VALVE receive FDA 510(k) clearance?

ADI CATHETER WITH VALVE received FDA 510(k) clearance on 1995-08-18, under 510(k) number K952924.

Who is the listed applicant for ADI CATHETER WITH VALVE?

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

What is the FDA product code for ADI CATHETER WITH VALVE?

The FDA product code for ADI CATHETER WITH VALVE is GBM.

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Other records listing Asia Dynamics, 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.

K953500HEMO-BARRIERK953501ADI STERILE GAUZE SPONGESK891160MIC NON-STERILE LATEX GLOVES

Related Devices (Code: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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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