PhasTIPP
FDA 510(k) K212894 · LeMaitre Vascular, Inc.
510(k) numberK212894
Submission
- Device name
- PhasTIPP
- Applicant
- LeMaitre Vascular, Inc.
Burlington, MA, US - Received
- September 10, 2021
- Decision date
- March 31, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWQ – Stripper, Vein, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4885
- Specialty
- Cardiovascular
Other 510(k)s with product code DWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041453 | Smith & Nephew Tumescent Catheter Inversion System, Model 7210023DWQ · Traditional | Smith & Nephew, Inc. | 07/22/2004SE |
| K032387 | Trivex SystemDWQ · Traditional | Smith & Nephew, Inc. | 10/29/2003SE |
| K905528 | Uresil Valve CutterDWQ · Traditional | Uresil Corp. | 04/18/1991SE |
| K904507 | Pilling Brush ValvulotomeDWQ · Traditional | Pilling Co. | 03/01/1991SE |
| K885046 | Insitucat Valve StripperDWQ · Traditional | Aesculap Instruments Corp. | 02/28/1990SE |
| K872157 | Hall Vein StripperDWQ · Traditional | Solco Basle, Inc. | 07/07/1987SE |
| K811910 | Vein-Trap TMDWQ · Traditional | Atrium Medical Corp. | 07/20/1981SE |
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Questions and answers
When was PhasTIPP cleared by the FDA?
PhasTIPP (K212894) received a 510(k) decision of Substantially Equivalent on March 31, 2022, 202 days after the submission was received.
What is the product code of K212894?
The FDA product code is DWQ – Stripper, Vein, External, a Class II (moderate risk) device regulated under 21 CFR 870.4885.