Monarch(Tm) Inflation Syringe
FDA 510(k) K913994 · Merit Medical Systems, Inc.
510(k) numberK913994
Submission
- Device name
- Monarch(Tm) Inflation Syringe
- Applicant
- Merit Medical Systems, Inc.
Salt Lake City, UT, US - Received
- September 6, 1991
- Decision date
- February 4, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K140943 | Mastro Plus Balloon In-Deflation DeviceMAV · Traditional | Beijing Demax Medical Technology Co.,Ltd | 03/05/2015SE |
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Questions and answers
When was Monarch(Tm) Inflation Syringe cleared by the FDA?
Monarch(Tm) Inflation Syringe (K913994) received a 510(k) decision of Substantially Equivalent on February 4, 1992, 151 days after the submission was received.
What is the product code of K913994?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.