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FDA 510(k)

AMNIOINFUSION CATHETER

K-Number: K862182 · 1986-08-25

ApplicantMichael Reese Hospital and Medical Center
Decision Date1986-08-25
Product CodeKXO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AMNIOINFUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Michael Reese Hospital and Medical Center. It received FDA 510(k) clearance on 1986-08-25 under 510(k) number K862182. The device is classified under product code KXO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMNIOINFUSION CATHETER?

AMNIOINFUSION CATHETER is a medical device that received FDA 510(k) clearance on 1986-08-25. The listed applicant is Michael Reese Hospital and Medical Center. The 510(k) number is K862182.

When did AMNIOINFUSION CATHETER receive FDA 510(k) clearance?

AMNIOINFUSION CATHETER received FDA 510(k) clearance on 1986-08-25, under 510(k) number K862182.

Who is the listed applicant for AMNIOINFUSION CATHETER?

The FDA 510(k) record lists Michael Reese Hospital and Medical Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMNIOINFUSION CATHETER?

The FDA product code for AMNIOINFUSION CATHETER is KXO.

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 Michael Reese Hospital and Medical Center 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.

K862181MECONIUM SUCTION TRAP

Related Devices (Code: KXO)

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.

K991235SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)Ludlow Technical ProductsK982565EASY TRANS TIPCarl SchuhK974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)Graphic Controls Corp.K964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)Graphic Controls Corp.K961290IUP - TIP TRANS, IUP - PROXI TRANSScientific Device Manufacturer, LLCK950498LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETERGraphic Controls Corp.

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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