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FDA 510(k)

CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)

K-Number: K971897 · 1997-10-21

ApplicantMedron, Inc.
Decision Date1997-10-21
Product CodeLFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) is the device name listed in this FDA 510(k) record. The listed applicant is Medron, Inc.. It received FDA 510(k) clearance on 1997-10-21 under 510(k) number K971897. The device is classified under product code LFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)?

CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) is a medical device that received FDA 510(k) clearance on 1997-10-21. The listed applicant is Medron, Inc.. The 510(k) number is K971897.

When did CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) receive FDA 510(k) clearance?

CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) received FDA 510(k) clearance on 1997-10-21, under 510(k) number K971897.

Who is the listed applicant for CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)?

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

What is the FDA product code for CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)?

The FDA product code for CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) is LFK.

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 Medron, 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.

K940775INJECTION CAP

Related Devices (Code: LFK)

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.

K914936CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SETAkcess Medical Products, Inc.K915215CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITSAkcess Medical Products, Inc.K891763FC-100 FEMORAL CATHETERAkcess Medical Products, Inc.K891764FC-101 FEMORAL CATHETER GUIDE WIREAkcess Medical Products, Inc.K890717MODIFICATION HEMOFILTRATION CATHETER HF-100Vas-Cath, Inc.K880775CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAYMedsurg Industries, 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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