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FDA 510(k)

LAWMAX DILATOR

K-Number: K123842 · 2013-06-24

ApplicantLifetech Scientific (Shenzhen) Co., Ltd.
Decision Date2013-06-24
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LAWMAX DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Lifetech Scientific (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2013-06-24 under 510(k) number K123842. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAWMAX DILATOR?

LAWMAX DILATOR is a medical device that received FDA 510(k) clearance on 2013-06-24. The listed applicant is Lifetech Scientific (Shenzhen) Co., Ltd.. The 510(k) number is K123842.

When did LAWMAX DILATOR receive FDA 510(k) clearance?

LAWMAX DILATOR received FDA 510(k) clearance on 2013-06-24, under 510(k) number K123842.

Who is the listed applicant for LAWMAX DILATOR?

The FDA 510(k) record lists Lifetech Scientific (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAWMAX DILATOR?

The FDA product code for LAWMAX DILATOR is DRE.

Related Clinical Trials

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Other records listing Lifetech Scientific (Shenzhen) Co., Ltd. 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.

K100184FUSTAR STEERABLE INTRODUCERSK102484SEQURE SNARE SYSTEM

Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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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