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FDA 510(k)

DUAL LUMEN NEEDLE (PRODUCT CHANGE)

K-Number: K860515 · 1986-03-04

ApplicantQuinton, Inc.
Decision Date1986-03-04
Product CodeLBW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DUAL LUMEN NEEDLE (PRODUCT CHANGE) is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1986-03-04 under 510(k) number K860515. 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 DUAL LUMEN NEEDLE (PRODUCT CHANGE)?

DUAL LUMEN NEEDLE (PRODUCT CHANGE) is a medical device that received FDA 510(k) clearance on 1986-03-04. The listed applicant is Quinton, Inc.. The 510(k) number is K860515.

When did DUAL LUMEN NEEDLE (PRODUCT CHANGE) receive FDA 510(k) clearance?

DUAL LUMEN NEEDLE (PRODUCT CHANGE) received FDA 510(k) clearance on 1986-03-04, under 510(k) number K860515.

Who is the listed applicant for DUAL LUMEN NEEDLE (PRODUCT CHANGE)?

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

What is the FDA product code for DUAL LUMEN NEEDLE (PRODUCT CHANGE)?

The FDA product code for DUAL LUMEN NEEDLE (PRODUCT CHANGE) is LBW.

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Other records listing Quinton, 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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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.K820859COAXIAL DUAL FLOW CATHETERTerumo Medical Corp.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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