Cleared Traditional

K212894 - PhasTIPP

K212894 is an FDA 510(k) clearance for PhasTIPP, manufactured by LeMaitre Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code DWQ cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K212894 · LeMaitre Vascular, Inc. · Cardiovascular device
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Mar 2022
Decision
202d
Days
Class 2
Risk

K212894 is an FDA 510(k) clearance for the PhasTIPP. Classified as Stripper, Vein, External (product code DWQ), Class II - Special Controls.

Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on March 31, 2022 after a review of 202 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4885 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all LeMaitre Vascular, Inc. devices

FDA 510(k) Submission Details - K212894

510(k) Number K212894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2021
Decision Date March 31, 2022
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWQ Device Classification - Class 2, Special Controls

Product Code DWQ Stripper, Vein, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4885
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWQ Stripper, Vein, External

Devices cleared under the same product code (DWQ) and FDA review panel - the closest regulatory comparables to K212894.
SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023
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K904507 · Pilling Co. · Mar 1991
VEIN-TRAP TM
K811910 · Atrium Medical Corp. · Jul 1981