Scimed Encore Inflation Device, Model SM2500
FDA 510(k) K903503 · Scimed
510(k) numberK903503
Submission
- Device name
- Scimed Encore Inflation Device, Model SM2500
- Applicant
- Scimed
Maple Grove, MN, US - Received
- August 3, 1990
- Decision date
- October 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K140943 | Mastro Plus Balloon In-Deflation DeviceMAV · Traditional | Beijing Demax Medical Technology Co.,Ltd | 03/05/2015SE |
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| K133795 | Summed Inflation Device KitMAV · Traditional | Sunny Medical Device (Shenzhen) Co., Ltd. | 12/12/2014SE |
| K140745 | Encore 26 Advantage KitMAV · Special | Boston Scientific Corp | 04/17/2014SESK |
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Questions and answers
When was Scimed Encore Inflation Device, Model SM2500 cleared by the FDA?
Scimed Encore Inflation Device, Model SM2500 (K903503) received a 510(k) decision of Substantially Equivalent on October 9, 1990, 67 days after the submission was received.
What is the product code of K903503?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.