En-Snare Endovascular Snare and Catheter
FDA 510(k) K021606 · Medical Device Technologies, Inc.
510(k) numberK021606
Submission
- Device name
- En-Snare Endovascular Snare and Catheter
- Applicant
- Medical Device Technologies, Inc.
Gainesville, FL, US - Received
- May 16, 2002
- Decision date
- May 31, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- MMX – Device, Percutaneous Retrieval
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
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Questions and answers
When was En-Snare Endovascular Snare and Catheter cleared by the FDA?
En-Snare Endovascular Snare and Catheter (K021606) received a 510(k) decision of Substantially Equivalent on May 31, 2002, 15 days after the submission was received.
What is the product code of K021606?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.