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FDA 510(k)

KM PRODUCTS ASPIRATING TUBING

K-Number: K850105 · 1985-03-21

ApplicantKm Products
Decision Date1985-03-21
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KM PRODUCTS ASPIRATING TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Km Products. It received FDA 510(k) clearance on 1985-03-21 under 510(k) number K850105. 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 KM PRODUCTS ASPIRATING TUBING?

KM PRODUCTS ASPIRATING TUBING is a medical device that received FDA 510(k) clearance on 1985-03-21. The listed applicant is Km Products. The 510(k) number is K850105.

When did KM PRODUCTS ASPIRATING TUBING receive FDA 510(k) clearance?

KM PRODUCTS ASPIRATING TUBING received FDA 510(k) clearance on 1985-03-21, under 510(k) number K850105.

Who is the listed applicant for KM PRODUCTS ASPIRATING TUBING?

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

What is the FDA product code for KM PRODUCTS ASPIRATING TUBING?

The FDA product code for KM PRODUCTS ASPIRATING TUBING is BSY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Km Products 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.

K850240KM PRODUCTS SUCTION TIPSK844200K.M. PRODUCTS ASPIRATOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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