Scimed Encore 26 Inflation Device/Encore 30 Inflation Device
FDA 510(k) K955869 · Scimed Life Systems, Inc.
510(k) numberK955869
Submission
- Device name
- Scimed Encore 26 Inflation Device/Encore 30 Inflation Device
- Applicant
- Scimed Life Systems, Inc.
Maple Grove, MN, US - Received
- December 26, 1995
- Decision date
- March 22, 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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| K133795 | Summed Inflation Device KitMAV · Traditional | Sunny Medical Device (Shenzhen) Co., Ltd. | 12/12/2014SE |
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Questions and answers
When was Scimed Encore 26 Inflation Device/Encore 30 Inflation Device cleared by the FDA?
Scimed Encore 26 Inflation Device/Encore 30 Inflation Device (K955869) received a 510(k) decision of Substantially Equivalent on March 22, 1996, 87 days after the submission was received.
What is the product code of K955869?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.