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FDA 510(k)

OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302

K-Number: K022145 · 2003-01-14

ApplicantLeMaitre Vascular, Inc.
Decision Date2003-01-14
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 is the device name listed in this FDA 510(k) record. The listed applicant is LeMaitre Vascular, Inc.. It received FDA 510(k) clearance on 2003-01-14 under 510(k) number K022145. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302?

OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 is a medical device that received FDA 510(k) clearance on 2003-01-14. The listed applicant is LeMaitre Vascular, Inc.. The 510(k) number is K022145.

When did OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 receive FDA 510(k) clearance?

OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 received FDA 510(k) clearance on 2003-01-14, under 510(k) number K022145.

Who is the listed applicant for OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302?

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

What is the FDA product code for OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302?

The FDA product code for OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 is DXE.

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Other records listing LeMaitre Vascular, Inc. as applicant

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Related Devices (Code: DXE)

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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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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