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FDA 510(k)

DUAL LUMEN L-CATH CATHETER SYSTEM

K-Number: K925979 · 1993-05-27

ApplicantLuther Medical Products, Inc.
Decision Date1993-05-27
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DUAL LUMEN L-CATH CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Luther Medical Products, Inc.. It received FDA 510(k) clearance on 1993-05-27 under 510(k) number K925979. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUAL LUMEN L-CATH CATHETER SYSTEM?

DUAL LUMEN L-CATH CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 1993-05-27. The listed applicant is Luther Medical Products, Inc.. The 510(k) number is K925979.

When did DUAL LUMEN L-CATH CATHETER SYSTEM receive FDA 510(k) clearance?

DUAL LUMEN L-CATH CATHETER SYSTEM received FDA 510(k) clearance on 1993-05-27, under 510(k) number K925979.

Who is the listed applicant for DUAL LUMEN L-CATH CATHETER SYSTEM?

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

What is the FDA product code for DUAL LUMEN L-CATH CATHETER SYSTEM?

The FDA product code for DUAL LUMEN L-CATH CATHETER SYSTEM is DQX.

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Other records listing Luther 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.

K982797BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICBK980090ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)K974543L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGERK940198L-CATH CONNECTOR ASSEMBLYK942103L-CATH CATHETER SYSTEM - PORT L-CATHK930473ONECATH L-CATH CATHETER SYSTEM

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Related Devices (Code: DQX)

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.

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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