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FDA 510(k)

AKCESS0CATH KIT

K-Number: K925819 · 1994-08-02

ApplicantAkcess Medical Products, Inc.
Decision Date1994-08-02
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AKCESS0CATH KIT 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 1994-08-02 under 510(k) number K925819. 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 AKCESS0CATH KIT?

AKCESS0CATH KIT is a medical device that received FDA 510(k) clearance on 1994-08-02. The listed applicant is Akcess Medical Products, Inc.. The 510(k) number is K925819.

When did AKCESS0CATH KIT receive FDA 510(k) clearance?

AKCESS0CATH KIT received FDA 510(k) clearance on 1994-08-02, under 510(k) number K925819.

Who is the listed applicant for AKCESS0CATH KIT?

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 AKCESS0CATH KIT?

The FDA product code for AKCESS0CATH KIT 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 KITSK925818AKCESS-CATHK930630RIGHT ATRIAL CATHETERK931120COAXIAL ACUTE CATHETERK920634SPLITTABLE SHEATH INTRODUCER SETK914936CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH 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.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.K914162VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERSVas-Cath, 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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