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FDA 510(k)

MODIFIED DECANNULATION STOPPER

K-Number: K894050 · 1989-08-01

ApplicantPremier Medical
Decision Date1989-08-01
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED DECANNULATION STOPPER is the device name listed in this FDA 510(k) record. The listed applicant is Premier Medical. It received FDA 510(k) clearance on 1989-08-01 under 510(k) number K894050. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED DECANNULATION STOPPER?

MODIFIED DECANNULATION STOPPER is a medical device that received FDA 510(k) clearance on 1989-08-01. The listed applicant is Premier Medical. The 510(k) number is K894050.

When did MODIFIED DECANNULATION STOPPER receive FDA 510(k) clearance?

MODIFIED DECANNULATION STOPPER received FDA 510(k) clearance on 1989-08-01, under 510(k) number K894050.

Who is the listed applicant for MODIFIED DECANNULATION STOPPER?

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

What is the FDA product code for MODIFIED DECANNULATION STOPPER?

The FDA product code for MODIFIED DECANNULATION STOPPER is JOH.

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 Premier Medical 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.

K896303BIOPSY PUNCHK884418PREMIER DIE-TRAK ARTICULATOR

Related Devices (Code: JOH)

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.

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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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