External Vein Stripper
FDA 510(k) K933498 · Applied Medical Resources
510(k) numberK933498
Submission
- Device name
- External Vein Stripper
- Applicant
- Applied Medical Resources
Launa Hills, CA, US - Received
- July 19, 1993
- Decision date
- March 23, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWX – Stripper, Artery, Intraluminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Specialty
- Cardiovascular
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Questions and answers
When was External Vein Stripper cleared by the FDA?
External Vein Stripper (K933498) received a 510(k) decision of Substantially Equivalent on March 23, 1994, 247 days after the submission was received.
What is the product code of K933498?
The FDA product code is DWX – Stripper, Artery, Intraluminal, a Class II (moderate risk) device regulated under 21 CFR 870.4875.