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FDA 510(k)

DUAL LUMEN NEEDLES

K-Number: K904433 · 1990-11-23

ApplicantAkcess Medical Products, Inc.
Decision Date1990-11-23
Product CodeLBW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DUAL LUMEN NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Akcess Medical Products, Inc.. It received FDA 510(k) clearance on 1990-11-23 under 510(k) number K904433. 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 NEEDLES?

DUAL LUMEN NEEDLES is a medical device that received FDA 510(k) clearance on 1990-11-23. The listed applicant is Akcess Medical Products, Inc.. The 510(k) number is K904433.

When did DUAL LUMEN NEEDLES receive FDA 510(k) clearance?

DUAL LUMEN NEEDLES received FDA 510(k) clearance on 1990-11-23, under 510(k) number K904433.

Who is the listed applicant for DUAL LUMEN NEEDLES?

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

What is the FDA product code for DUAL LUMEN NEEDLES?

The FDA product code for DUAL LUMEN NEEDLES is LBW.

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Other records listing Akcess Medical Products, 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.

K926374SILICONE CATHETER REPAIR KITSK925819AKCESS0CATH KITK925818AKCESS-CATHK930630RIGHT ATRIAL CATHETERK931120COAXIAL ACUTE CATHETERK920634SPLITTABLE SHEATH INTRODUCER SET

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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.

K864629MODIFIED DUAL LUMEN NEEDLEQuinton, Inc.K860515DUAL LUMEN NEEDLE (PRODUCT CHANGE)Quinton, 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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