Lemaitre Vascular Disposable Vein Stripper
FDA 510(k) K023688 · LeMaitre Vascular, Inc.
510(k) numberK023688
Submission
- Device name
- Lemaitre Vascular Disposable Vein Stripper
- Applicant
- LeMaitre Vascular, Inc.
Burlington, MA, US - Received
- November 1, 2002
- Decision date
- January 30, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAF – Spatula, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K882793 | PMT Fukushima Microsurgical Instrument LineGAF · Traditional | Pmt Corp. | 07/18/1988SE |
| K822108 | Cement-PickGAF · Traditional | Bio-Blitz, Inc. | 08/11/1982SE |
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Questions and answers
When was Lemaitre Vascular Disposable Vein Stripper cleared by the FDA?
Lemaitre Vascular Disposable Vein Stripper (K023688) received a 510(k) decision of Substantially Equivalent on January 30, 2003, 90 days after the submission was received.
What is the product code of K023688?
The FDA product code is GAF – Spatula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.