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FDA 510(k)

DUAL LUMEN CATHETER, MODEL DL-35-90

K-Number: K991601 · 1999-10-28

ApplicantEndologix, Inc.
Decision Date1999-10-28
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DUAL LUMEN CATHETER, MODEL DL-35-90 is the device name listed in this FDA 510(k) record. The listed applicant is Endologix, Inc.. It received FDA 510(k) clearance on 1999-10-28 under 510(k) number K991601. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUAL LUMEN CATHETER, MODEL DL-35-90?

DUAL LUMEN CATHETER, MODEL DL-35-90 is a medical device that received FDA 510(k) clearance on 1999-10-28. The listed applicant is Endologix, Inc.. The 510(k) number is K991601.

When did DUAL LUMEN CATHETER, MODEL DL-35-90 receive FDA 510(k) clearance?

DUAL LUMEN CATHETER, MODEL DL-35-90 received FDA 510(k) clearance on 1999-10-28, under 510(k) number K991601.

Who is the listed applicant for DUAL LUMEN CATHETER, MODEL DL-35-90?

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

What is the FDA product code for DUAL LUMEN CATHETER, MODEL DL-35-90?

The FDA product code for DUAL LUMEN CATHETER, MODEL DL-35-90 is DQY.

Related Clinical Trials

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 Endologix, 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.

K120212AFX INTRODUCER SYSTEMK111747ENDOLOGIX AFX INTRODUCER SYSTEMK110090AFX INTRODUCER SYSTEMK080360ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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