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FDA 510(k)

AKCESS-CATH

K-Number: K925818 · 1994-04-05

ApplicantAkcess Medical Products, Inc.
Decision Date1994-04-05
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AKCESS-CATH 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 1994-04-05 under 510(k) number K925818. 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 AKCESS-CATH?

AKCESS-CATH is a medical device that received FDA 510(k) clearance on 1994-04-05. The listed applicant is Akcess Medical Products, Inc.. The 510(k) number is K925818.

When did AKCESS-CATH receive FDA 510(k) clearance?

AKCESS-CATH received FDA 510(k) clearance on 1994-04-05, under 510(k) number K925818.

Who is the listed applicant for AKCESS-CATH?

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 AKCESS-CATH?

The FDA product code for AKCESS-CATH is LFJ.

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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.

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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 KITK930630RIGHT ATRIAL CATHETERK931120COAXIAL ACUTE CATHETERK920634SPLITTABLE SHEATH INTRODUCER SETK914936CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET

View all 36 devices →

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.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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