Ethibond Excel Valve Loop Suture
FDA 510(k) K003070 · ETHICON, Inc.
510(k) numberK003070
Submission
- Device name
- Ethibond Excel Valve Loop Suture
- Applicant
- ETHICON, Inc.
Somerville, NJ, US - Received
- October 2, 2000
- Decision date
- November 7, 2000
- 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 Ethibond Excel Valve Loop Suture cleared by the FDA?
Ethibond Excel Valve Loop Suture (K003070) received a 510(k) decision of Substantially Equivalent on November 7, 2000, 36 days after the submission was received.
What is the product code of K003070?
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.