Fogarty Valvulotome Model 700091
FDA 510(k) K965137 · Baxter Edwards
510(k) numberK965137
Submission
- Device name
- Fogarty Valvulotome Model 700091
- Applicant
- Baxter Edwards
Irvine, CA, US - Received
- December 23, 1996
- Decision date
- June 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MGZ – Valvulotome
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4885
- Specialty
- Cardiovascular
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Questions and answers
When was Fogarty Valvulotome Model 700091 cleared by the FDA?
Fogarty Valvulotome Model 700091 (K965137) received a 510(k) decision of Substantially Equivalent on June 4, 1997, 163 days after the submission was received.
What is the product code of K965137?
The FDA product code is MGZ – Valvulotome, a Class II (moderate risk) device regulated under 21 CFR 870.4885.