Albosure Polyester Vascular Patch
FDA 510(k) K101740 · LeMaitre Vascular, Inc.
510(k) numberK101740
Submission
- Device name
- Albosure Polyester Vascular Patch
- Applicant
- LeMaitre Vascular, Inc.
Bedford, MA, US - Received
- June 21, 2010
- Decision date
- September 20, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Specialty
- Cardiovascular
- Implant
- Yes
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Questions and answers
When was Albosure Polyester Vascular Patch cleared by the FDA?
Albosure Polyester Vascular Patch (K101740) received a 510(k) decision of Substantially Equivalent on September 20, 2010, 91 days after the submission was received.
What is the product code of K101740?
The FDA product code is DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 870.3470.