Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KAWASUMI A.V. FISTULA SET

K-Number: K873421 · 1987-10-09

ApplicantKawasumi Laboratories Co., Ltd.
Decision Date1987-10-09
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KAWASUMI A.V. FISTULA SET is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories Co., Ltd.. It received FDA 510(k) clearance on 1987-10-09 under 510(k) number K873421. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAWASUMI A.V. FISTULA SET?

KAWASUMI A.V. FISTULA SET is a medical device that received FDA 510(k) clearance on 1987-10-09. The listed applicant is Kawasumi Laboratories Co., Ltd.. The 510(k) number is K873421.

When did KAWASUMI A.V. FISTULA SET receive FDA 510(k) clearance?

KAWASUMI A.V. FISTULA SET received FDA 510(k) clearance on 1987-10-09, under 510(k) number K873421.

Who is the listed applicant for KAWASUMI A.V. FISTULA SET?

The FDA 510(k) record lists Kawasumi Laboratories Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KAWASUMI A.V. FISTULA SET?

The FDA product code for KAWASUMI A.V. FISTULA SET is FKQ.

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 Kawasumi Laboratories Co., Ltd. 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.

K994323KAWASUMI LABORATORIES PHILEBOTOMY SETK974829NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)K964117NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITEK935514VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDERK935505WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTERK935506MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION

View all 18 devices →

Related Devices (Code: FKQ)

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.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, Inc.K864635FOUR TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.

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.

↑