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FDA 510(k)

PhasTIPP

K-Number: K212894 · 2022-03-31

ApplicantLeMaitre Vascular, Inc.
Decision Date2022-03-31
Product CodeDWQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PhasTIPP 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 2022-03-31 under 510(k) number K212894. The device is classified under product code DWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PhasTIPP?

PhasTIPP is a medical device that received FDA 510(k) clearance on 2022-03-31. The listed applicant is LeMaitre Vascular, Inc.. The 510(k) number is K212894.

When did PhasTIPP receive FDA 510(k) clearance?

PhasTIPP received FDA 510(k) clearance on 2022-03-31, under 510(k) number K212894.

Who is the listed applicant for PhasTIPP?

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 PhasTIPP?

The FDA product code for PhasTIPP is DWQ.

Other records listing LeMaitre Vascular, 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.

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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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