Medtronic Everst 30 Inflation Device/Survival Kit
FDA 510(k) K960983 · Medtronics Interventional Vascular
510(k) numberK960983
Submission
- Device name
- Medtronic Everst 30 Inflation Device/Survival Kit
- Applicant
- Medtronics Interventional Vascular
Danvers, MA, US - Received
- March 11, 1996
- Decision date
- May 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAV – Syringe, Balloon Inflation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
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Questions and answers
When was Medtronic Everst 30 Inflation Device/Survival Kit cleared by the FDA?
Medtronic Everst 30 Inflation Device/Survival Kit (K960983) received a 510(k) decision of Substantially Equivalent on May 30, 1996, 80 days after the submission was received.
What is the product code of K960983?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.