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FDA 510(k)

COAXIAL DUAL FLOW CATHETER

K-Number: K820859 · 1982-04-16

ApplicantTerumo Medical Corp.
Decision Date1982-04-16
Product CodeLBW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COAXIAL DUAL FLOW CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1982-04-16 under 510(k) number K820859. The device is classified under product code LBW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAXIAL DUAL FLOW CATHETER?

COAXIAL DUAL FLOW CATHETER is a medical device that received FDA 510(k) clearance on 1982-04-16. The listed applicant is Terumo Medical Corp.. The 510(k) number is K820859.

When did COAXIAL DUAL FLOW CATHETER receive FDA 510(k) clearance?

COAXIAL DUAL FLOW CATHETER received FDA 510(k) clearance on 1982-04-16, under 510(k) number K820859.

Who is the listed applicant for COAXIAL DUAL FLOW CATHETER?

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

What is the FDA product code for COAXIAL DUAL FLOW CATHETER?

The FDA product code for COAXIAL DUAL FLOW CATHETER is LBW.

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Other records listing Terumo Medical Corp. 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.

K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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Related Devices (Code: LBW)

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.

K904433DUAL LUMEN NEEDLESAkcess Medical Products, Inc.K864629MODIFIED DUAL LUMEN NEEDLEQuinton, Inc.K860515DUAL LUMEN NEEDLE (PRODUCT CHANGE)Quinton, Inc.K801968HEMOCATH I KIDNEY DIALYSIS CATHETERMedical Components, 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.

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