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FDA 510(k)

SINGLE LUMEN CATHETERS, MODIFICATION

K-Number: K904140 · 1990-11-27

ApplicantAkcess Medical Products, Inc.
Decision Date1990-11-27
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SINGLE LUMEN CATHETERS, MODIFICATION 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 1990-11-27 under 510(k) number K904140. The device is classified under product code LFJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE LUMEN CATHETERS, MODIFICATION?

SINGLE LUMEN CATHETERS, MODIFICATION is a medical device that received FDA 510(k) clearance on 1990-11-27. The listed applicant is Akcess Medical Products, Inc.. The 510(k) number is K904140.

When did SINGLE LUMEN CATHETERS, MODIFICATION receive FDA 510(k) clearance?

SINGLE LUMEN CATHETERS, MODIFICATION received FDA 510(k) clearance on 1990-11-27, under 510(k) number K904140.

Who is the listed applicant for SINGLE LUMEN CATHETERS, MODIFICATION?

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 SINGLE LUMEN CATHETERS, MODIFICATION?

The FDA product code for SINGLE LUMEN CATHETERS, MODIFICATION is LFJ.

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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: LFJ)

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.

K920780MEDSURG INSERTION TRAYMedsurg Industries, Inc.K925819AKCESS0CATH KITAkcess Medical Products, Inc.K925818AKCESS-CATHAkcess Medical Products, Inc.K913468ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAYCook, Inc.K931120COAXIAL ACUTE CATHETERAkcess Medical Products, Inc.K920634SPLITTABLE SHEATH INTRODUCER SETAkcess Medical Products, 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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