Angeion Igital Angeflator
FDA 510(k) K921757 · Angeion Corp.
510(k) numberK921757
Submission
- Device name
- Angeion Igital Angeflator
- Applicant
- Angeion Corp.
Plymouth, MN, US - Received
- April 13, 1992
- Decision date
- March 18, 1993
- 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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| K162272 | Fluent inflation deviceMAV · Special | Vascular Solutions, Inc. | 10/20/2016SE |
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| K153672 | basixTOUCH40 Inflation SyringeMAV · Special | Merit Medical Systems, Inc. | 01/20/2016SESK |
| K152387 | Fluent Inflation DeviceMAV · Traditional | Vascular Solutions, Inc. | 12/18/2015SESK |
| K140943 | Mastro Plus Balloon In-Deflation DeviceMAV · Traditional | Beijing Demax Medical Technology Co.,Ltd | 03/05/2015SE |
| K143522 | Presto Inflation DeviceMAV · Traditional | C.R. Bard, Inc. | 01/12/2015SE |
| 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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|---|---|---|
| K925533 | Angestat(R) Pericardial Drainage Sheath SetGBX · Traditional | 01/12/1993SE |
| K915719 | Angeion Endoscopic Valve SealODC · Traditional | 02/18/1992SE |
| K902377 | Angeflator(Tm)DXT · Traditional | 12/13/1990SE |
| K895580 | Y-Adapter W/Thouy BorstDYB · Traditional | 04/30/1990SE |
| K894446 | Angeion Hemostasis Valve IntroducerDYB · Traditional | 11/30/1989SE |
| K871153 | Catheter IntroducerDYB · Traditional | 06/24/1987SE |
Questions and answers
When was Angeion Igital Angeflator cleared by the FDA?
Angeion Igital Angeflator (K921757) received a 510(k) decision of Substantially Equivalent on March 18, 1993, 339 days after the submission was received.
What is the product code of K921757?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.