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FDA 510(k)

DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K

K-Number: K891755 · 1989-06-08

ApplicantAkcess Medical Products, Inc.
Decision Date1989-06-08
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K 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 1989-06-08 under 510(k) number K891755. 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 DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K?

DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K is a medical device that received FDA 510(k) clearance on 1989-06-08. The listed applicant is Akcess Medical Products, Inc.. The 510(k) number is K891755.

When did DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K receive FDA 510(k) clearance?

DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K received FDA 510(k) clearance on 1989-06-08, under 510(k) number K891755.

Who is the listed applicant for DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K?

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 SUB-CLAVIAN CATH KIT, DLSC 600K & 800K?

The FDA product code for DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K 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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