PhasTIPP Vein Stripper, External
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212894 FDA 510(k)
- FDA Product Code
- DWQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4885 FDA 510(k)
- Regulation Number
- 870.4885 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PhasTIPP Vein Stripper, External is an external vein stripper designed for use in vascular procedures. Classified under product code DWQ, it falls under the regulatory category of external vein strippers, intended for assisting in the removal of veins during surgical interventions.
This device is supplied as a single-use, reusable component and is regulated under 21 CFR 870.4885. It is intended for use in cardiovascular settings and has received FDA 510(k) clearance (K212894) as substantially equivalent to a predicate device. Storage and handling follow standard sterile or non-sterile protocols as specified by the manufacturer.
Frequently asked questions
What is the PhasTIPP Vein Stripper, External used for in clinical practice?
The PhasTIPP Vein Stripper, External is designed to assist in the removal of veins during surgical procedures, specifically within cardiovascular settings. It is classified as an external vein stripper and is intended for use as an adjunct tool in vein stripping interventions.
Is the PhasTIPP Vein Stripper, External intended for single-use or can it be reused?
The PhasTIPP Vein Stripper, External is supplied as a single-use device, though it includes a reusable component as part of its design. This distinction is important for infection control and compliance with sterile handling protocols.
How should the PhasTIPP Vein Stripper, External be stored and handled?
Storage and handling of the PhasTIPP Vein Stripper, External follow standard protocols for either sterile or non-sterile devices, as specified by the manufacturer. Since it is a medical device used in surgical settings, adherence to these guidelines ensures proper functionality and patient safety.
What regulatory pathway was followed for the FDA clearance of the PhasTIPP Vein Stripper, External?
The PhasTIPP Vein Stripper, External received FDA clearance through a 510(k) submission (K212894) under the Traditional review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. It falls under the Cardiovascular (CV) advisory committee and is classified under product code DWQ, regulated by 21 CFR 870.4885.
What types of sizes or models are available for the PhasTIPP Vein Stripper, External?
The PhasTIPP Vein Stripper, External is available in multiple configurations, as indicated by the OpenFDA registration numbers (e.g., 3010041511, 3005747797, etc.), which suggest variations in design or sizing. For precise details on available models, refer to the manufacturer’s catalog or technical documentation, as these identifiers correspond to different product variants.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PhasTIPP® System | LeMaitre, K212894 FDA 510(k) - PhasTIPP | LeMaitre Vascular, Inc., PDF LeMaitre Vascular Inc. Anurag Gadgil Sr. Regulatory Affairs Specialist ..., Phastipp 510 (k) FDA Premarket Notification K212894 LeMaitre Vascular Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212894 | Class II | Active |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
Sources (1)
- FDA 510(k) K212894 24 fields · synced Sep 20, 2026